Hepatitis C, Chronic
Conditions
Brief summary
This randomized, cross-over, open label study will compare the tolerability and handling of application of peginterferon alfa-2a \[Pegasys\] by autoinjector versus pre-filled syringe in patients with chronic hepatitis C, either on treatment with peginterferon alfa-2a for at least 12 weeks or treatment-naïve for peginterferon alfa-2a. Patients will be randomized to self-injection of 180mcg peginterferon alfa-2a once a week using either an autoinjector or a prefilled syringe for 3 weeks, then switch to use the other method of injection for another 3 weeks. Anticipated time on study treatment is 6 weeks. Target sample size is \<100 patients.
Interventions
DEVICEAutoinjector
Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.
DEVICEPre-filled syringe
Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>/=18 years of age * chronic hepatitis C * on treatment with peginterferon alfa-2a for \>/= 12 weeks at baseline, or treatment-naïve for peginterferon alfa-2a
Exclusion criteria
* history or evidence of decompensated liver disease * autoimmune hepatitis * hypersensitivity to peginterferon alfa-2a or any of its components * concomitant treatment that requires administration by self-injection, or prior use of an autoinjector
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days) | The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a Yes or No response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Marked Laboratory Abnormalities in Hematocrit | Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) | A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hematocrit was 0.31-0.56 fraction. The clinical relevant change (decrease/ increase) for hematocrit was (15%, 15%). |
| Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) | A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Platelets was 100-550 (10\*9/L), for WBC was 3.0-18.0 (10\*9/L), for Basophils was 0.00-0.40 (10\*9/L), for Eosinophil was 0.00-0.90 (10\*9/L), for Lymphocytes was 0.70-7.60 (10\*9/L), Monocyte was 0.00-1.70 (10\*9/L), and Neutrophil 1.50-9.25 (10\*9/L). The clinical relevant change (decrease/increase) for platelet was (30%, 50%), WBC was (30%, 30%), Basophil was (n.d, 100%), Eosinophil was (n.d, 100%), Lymphocyte was (30%, 30%), Monocyte was (n.d, 100%) and Neutrophil was (20%, 20%) respectively. |
| Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC) | Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) | A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for RBC was 3.80-6.10 (10\*12/L). The clinical relevant change (decrease/ increase) for RBC was (15%, 15%). |
| Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR) | Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) | A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for PT-INR was n.d.-2.00. The clinical relevant change (decrease/ increase) for PT-INR was (n.d, 30%). |
| Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase | Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) | A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for SGOT was 0-80 (Units Per Litre \[U/L\]), SGPT was 0-110 U/L, and alkaline phosphatase was 0-220 U/L. The clinical relevant change (decrease/ increase) for SGOT was (n.d, 50%), SGPT was (n.d, 50%), and ALP was (n.d, 50%) respectively. |
| Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) | A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hemoglobin was 110-200 (gram per liter \[g/L\]), albumin was 30.0-n.d g/L, and total protein was 55-87 g/L. The clinical relevant change (decrease/ increase) for hemoglobin was (15%, 15%), albumin was (20%, n.d) and total protein was (20%, 20%) respectively. |
| Number of Participants With Marked Laboratory Abnormalities in Creatinine | Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) | A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Creatinine was 0- 154 (micromoles/liter \[umol/L\]). The clinical relevant change (decrease/ increase) for Creatinine was (n.d, 50%). |
| Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days) | The pulse rate, temperature and blood pressure was assessed during a physical examination. Pulse rate was assessed in beats per minute (bpm), temperature was assessed in degree Celsius (°С), and blood pressure was assessed in millimeters of mercury (mmHg). Vital signs were taken while the participant was supine. |
| Number of Participants With Abnormalities in Electrocardiograms | Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) | A 12-lead ECG was recorded after the participant had been in a semi-supine position for at least 10 minutes. Any clinically significant abnormalities noted on an ECG after the first dose of study drug were captured as AEs |
| Number of Participants With Adverse Events (AE) | Upto Day 36 | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days) | A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for BUN was 0.0-14.3 (millimoles per Liter \[mmol/L\]), Chloride was 95-115 (mmol/L), Potassium was 2.9-5.8 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), and Glucose was 2.80-11.10 (mmol/L). The clinical relevant change (decrease/ increase) for BUN was (n.d, 50%), Chloride was (7%, 7%), Potassium was (20%, 20%), Sodium was (7%, 7%), Calcium was (10%, 10%), and Glucose was (75%, 75%) respectively. |
Countries
United States
Participant flow
Recruitment details
A total of 60 participant's data were included from USA (10 centers). The inclusion period was between 11th March 2010 and 28th May 2010.
Pre-assignment details
This was a two-arm, randomized, crossover study in adult participants with hepatitis C infection. Participants were randomly assigned to one of two groups, in which they received injections by either pre-filled syringe (PFS) or autoinjector (AI) for the first 3 weeks and then switched to the other injection method for an additional 3 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants received PEG-IFN alfa-2a 180 mcg SC once a week either AI or PFS for the first 3 weeks and then switched to the other method of injection for an additional 3 weeks. Participants also received ribavirin according to standard of care per the investigator's judgment. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (Week 1-3) | Adverse Event | 1 | 0 |
| Period 2 (Week 4-6) | Adverse Event | 0 | 2 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 49.5 Years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 60 | 32 / 59 |
| serious Total, serious adverse events | 2 / 60 | 0 / 59 |
Outcome results
Primary
Feasibility of Peginterferon Alfa-2a Administration by Autoinjector
The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a Yes or No response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?
Time frame: Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)
Population: The intent-to-treat (ITT) population included all participants who received at least one injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Nervousness, No | 56 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Technical problems, No | 53 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Confidence, Yes | 58 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Technical problems, Yes | 3 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Nervousness, Yes | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Technical problems, No | 54 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Confidence, No | 2 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Withdrawal before completion, Yes | 4 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Difficulty initiating, Yes | 7 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Withdrawal before completion, No | 56 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Confidence, Yes | 58 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Withdrawal before completion, Yes | 1 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Withdrawal before completion, No | 57 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Technical problems, No | 53 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Withdrawal before completion, Yes | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Confidence, No | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Withdrawal before completion, No | 57 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Difficulty initiating, No | 53 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Pain/Discomfort, Yes | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Confidence, Yes | 57 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Pain/Discomfort, No | 60 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Nervousness, No | 58 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Pain/Discomfort, Yes | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Confidence, No | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Pain/Discomfort, No | 58 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Difficulty initiating, Yes | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Pain/Discomfort, Yes | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Following instruction, Yes | 58 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Pain/Discomfort, No | 57 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Nervousness, No | 49 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Satisfaction, Yes | 60 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Following instruction, No | 2 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Satisfaction, No | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Difficulty initiating, No | 58 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Satisfaction, Yes | 58 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Following instruction, Yes | 53 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Satisfaction, No | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Nervousness, Yes | 1 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Satisfaction, Yes | 57 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Following instruction, No | 5 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Satisfaction, No | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Difficulty initiating, Yes | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Frustration, Yes | 1 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Following instruction, Yes | 55 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Frustration, No | 59 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Nervousness, Yes | 11 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Frustration, Yes | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Following instruction, No | 2 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Frustration, No | 58 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Difficulty initiating, No | 57 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Frustration, Yes | 0 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Technical problems, Yes | 7 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Frustration, No | 57 participants |
| Autoinjector | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Technical problems, Yes | 5 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Frustration, No | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Withdrawal before completion, Yes | 0 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Technical problems, Yes | 2 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Technical problems, No | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Nervousness, Yes | 14 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Nervousness, No | 45 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Nervousness, Yes | 3 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Nervousness, No | 56 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Nervousness, Yes | 2 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Nervousness, No | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Difficulty initiating, Yes | 10 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Difficulty initiating, No | 49 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Difficulty initiating, Yes | 2 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Difficulty initiating, No | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Difficulty initiating, Yes | 2 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Difficulty initiating, No | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Confidence, Yes | 46 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Confidence, No | 13 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Confidence, Yes | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Confidence, No | 2 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Confidence, Yes | 58 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Confidence, No | 1 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Following instruction, Yes | 54 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Following instruction, No | 5 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Following instruction, Yes | 53 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Following instruction, No | 6 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Following instruction, Yes | 56 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Following instruction, No | 3 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Technical problems, Yes | 1 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Technical problems, No | 58 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Technical problems, Yes | 3 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Technical problems, No | 56 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Withdrawal before completion, Yes | 0 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Withdrawal before completion, No | 59 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Withdrawal before completion, No | 59 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Withdrawal before completion, Yes | 1 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Withdrawal before completion, No | 58 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Pain/Discomfort, Yes | 2 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Pain/Discomfort, No | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Pain/Discomfort, Yes | 1 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Pain/Discomfort, No | 58 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Pain/Discomfort, Yes | 2 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Pain/Discomfort, No | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Satisfaction, Yes | 51 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Satisfaction, No | 8 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Satisfaction, Yes | 55 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Satisfaction, No | 4 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Satisfaction, Yes | 56 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Satisfaction, No | 3 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Frustration, Yes | 2 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 1, Frustration, No | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Frustration, Yes | 2 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 2, Frustration, No | 57 participants |
| Pre-filled Syringe | Feasibility of Peginterferon Alfa-2a Administration by Autoinjector | Injection 3, Frustration, Yes | 2 participants |
Secondary
Number of Participants With Abnormalities in Electrocardiograms
A 12-lead ECG was recorded after the participant had been in a semi-supine position for at least 10 minutes. Any clinically significant abnormalities noted on an ECG after the first dose of study drug were captured as AEs
Time frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autoinjector | Number of Participants With Abnormalities in Electrocardiograms | 2 participants |
| Pre-filled Syringe | Number of Participants With Abnormalities in Electrocardiograms | 2 participants |
Secondary
Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure
The pulse rate, temperature and blood pressure was assessed during a physical examination. Pulse rate was assessed in beats per minute (bpm), temperature was assessed in degree Celsius (°С), and blood pressure was assessed in millimeters of mercury (mmHg). Vital signs were taken while the participant was supine.
Time frame: Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autoinjector | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | High Pulse Rate | 3 participants |
| Autoinjector | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | Low Pulse Rate | 0 participants |
| Autoinjector | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | High Systolic Blood Pressure | 7 participants |
| Autoinjector | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | Low Systolic Blood Pressure | 0 participants |
| Autoinjector | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | High Diastolic Blood Pressure | 9 participants |
| Autoinjector | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | Low Diastolic Blood Pressure | 0 participants |
| Autoinjector | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | High Temperature | 0 participants |
| Autoinjector | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | Low Temperature | 0 participants |
| Pre-filled Syringe | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | Low Temperature | 0 participants |
| Pre-filled Syringe | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | High Pulse Rate | 4 participants |
| Pre-filled Syringe | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | High Diastolic Blood Pressure | 5 participants |
| Pre-filled Syringe | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | Low Pulse Rate | 0 participants |
| Pre-filled Syringe | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | High Temperature | 0 participants |
| Pre-filled Syringe | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | High Systolic Blood Pressure | 10 participants |
| Pre-filled Syringe | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | Low Diastolic Blood Pressure | 0 participants |
| Pre-filled Syringe | Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure | Low Systolic Blood Pressure | 0 participants |
Secondary
Number of Participants With Adverse Events (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Upto Day 36
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autoinjector | Number of Participants With Adverse Events (AE) | 34 participants |
| Pre-filled Syringe | Number of Participants With Adverse Events (AE) | 38 participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for BUN was 0.0-14.3 (millimoles per Liter \[mmol/L\]), Chloride was 95-115 (mmol/L), Potassium was 2.9-5.8 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), and Glucose was 2.80-11.10 (mmol/L). The clinical relevant change (decrease/ increase) for BUN was (n.d, 50%), Chloride was (7%, 7%), Potassium was (20%, 20%), Sodium was (7%, 7%), Calcium was (10%, 10%), and Glucose was (75%, 75%) respectively.
Time frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Potassium (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Sodium (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Chloride (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Calcium (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Potassium (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Calcium (n=58, 58) | 2 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Chloride (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Glucose (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Sodium (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Glucose (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High BUN (n=57, 57) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Glucose (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High BUN (n=57, 57) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Chloride (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Chloride (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Potassium (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Potassium (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Sodium (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Sodium (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Calcium (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | Low Calcium (n=58, 58) | 2 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose | High Glucose (n=58, 58) | 0 participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Creatinine
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Creatinine was 0- 154 (micromoles/liter \[umol/L\]). The clinical relevant change (decrease/ increase) for Creatinine was (n.d, 50%).
Time frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Creatinine | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Creatinine | 0 participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Hematocrit
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hematocrit was 0.31-0.56 fraction. The clinical relevant change (decrease/ increase) for hematocrit was (15%, 15%).
Time frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Hematocrit | High Hematocrit (n=58, 58) | 1 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Hematocrit | Low Hematocrit (n=58, 58) | 3 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Hematocrit | High Hematocrit (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Hematocrit | Low Hematocrit (n=58, 58) | 1 participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hemoglobin was 110-200 (gram per liter \[g/L\]), albumin was 30.0-n.d g/L, and total protein was 55-87 g/L. The clinical relevant change (decrease/ increase) for hemoglobin was (15%, 15%), albumin was (20%, n.d) and total protein was (20%, 20%) respectively.
Time frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | Low Hemoglobin (n=58, 58) | 3 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | Low Total Protein (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | High Total Protein (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | Low Albumin (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | High Hemoglobin (n=58, 58) | 1 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | Low Albumin (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | High Hemoglobin (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | Low Hemoglobin (n=58, 58) | 3 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | High Total Protein (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein | Low Total Protein (n=58, 58) | 0 participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Platelets was 100-550 (10\*9/L), for WBC was 3.0-18.0 (10\*9/L), for Basophils was 0.00-0.40 (10\*9/L), for Eosinophil was 0.00-0.90 (10\*9/L), for Lymphocytes was 0.70-7.60 (10\*9/L), Monocyte was 0.00-1.70 (10\*9/L), and Neutrophil 1.50-9.25 (10\*9/L). The clinical relevant change (decrease/increase) for platelet was (30%, 50%), WBC was (30%, 30%), Basophil was (n.d, 100%), Eosinophil was (n.d, 100%), Lymphocyte was (30%, 30%), Monocyte was (n.d, 100%) and Neutrophil was (20%, 20%) respectively.
Time frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | Low White Blood Cells (n=58, 57) | 11 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Lymphocyte (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High White Blood Cells (n=58, 57) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | Low Lymphocyte (n=58, 58) | 5 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Basophil (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Monocyte (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | Low Platelets (n=57, 58) | 5 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Neutrophil (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Eosinophil (n=58, 58) | 0 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | Low Neutrophil (n=58, 58) | 20 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Platelets (n=57, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | Low Neutrophil (n=58, 58) | 19 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Platelets (n=57, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | Low Platelets (n=57, 58) | 3 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High White Blood Cells (n=58, 57) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | Low White Blood Cells (n=58, 57) | 9 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Basophil (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Eosinophil (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Lymphocyte (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | Low Lymphocyte (n=58, 58) | 1 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Monocyte (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil | High Neutrophil (n=58, 58) | 0 participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR)
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for PT-INR was n.d.-2.00. The clinical relevant change (decrease/ increase) for PT-INR was (n.d, 30%).
Time frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR) | 0 participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC)
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for RBC was 3.80-6.10 (10\*12/L). The clinical relevant change (decrease/ increase) for RBC was (15%, 15%).
Time frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC) | High Red Blood Cells (n=57, 57) | 1 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC) | Low Red Blood Cells (n=57, 57) | 1 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC) | High Red Blood Cells (n=57, 57) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC) | Low Red Blood Cells (n=57, 57) | 1 participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase
A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for SGOT was 0-80 (Units Per Litre \[U/L\]), SGPT was 0-110 U/L, and alkaline phosphatase was 0-220 U/L. The clinical relevant change (decrease/ increase) for SGOT was (n.d, 50%), SGPT was (n.d, 50%), and ALP was (n.d, 50%) respectively.
Time frame: Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)
Population: The ITT population included all participants who received at least one injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase | High SGOT (n=58, 58) | 4 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase | High SGPT (n=58, 58) | 2 participants |
| Autoinjector | Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase | High Alkaline Phosphatase (n=58, 58) | 0 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase | High SGOT (n=58, 58) | 4 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase | High SGPT (n=58, 58) | 1 participants |
| Pre-filled Syringe | Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase | High Alkaline Phosphatase (n=58, 58) | 0 participants |