Chronic Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, pegylated interferon, PegIntron Pen, Ribavirin
Brief summary
This is a non-interventional study designed to evaluate the efficacy and safety of combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were enrolled into study.
Detailed description
Participants with positive genotype-1 HCV RNA received 48 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants who were non-genotype-1 HCV RNA positive received 24 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants were asked to complete a questionnaire to measure the satisfaction and the use of training materials of PegIntron pen using a 1-5 score system provided in the questionnaire. The questionnaire was completed once at first follow-up visit. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 of treatment and at week-24 of follow-up in positive Non-genotype-1 HCV RNA participants. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 and at week-48 of treatment, and at week-24 of follow-up, for positive Genotype-1 HCV RNA participants.
Interventions
DRUGPegIntron Pen
Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.
DRUGRibavirin
Dose is based on body weight. Each tablet of ribavirin is 200mg, and given by oral administration. Participants with body weight of \<65 kg were administered 800 mg of ribavirin daily, body weight of 65 kg-85 kg received 1000 mg daily, and participants with a body weight of \>85 kg received 1200 mg of ribavirin daily.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent. * Equal to or greater than 18 years. * Confirmed chronic hepatitis C with hepatitis C virus (HCV) RNA positive in plasma. * No previous use of PegIntron Pen.
Exclusion criteria
* Hypersensitivity to the active substance or to any interferon or to any of the excipients. * Pregnant women. * Women who are breastfeeding. * Existence of or a history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt. * A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months. * Severe debilitating medical condition, including patients with chronic renal failure or creatinine clearance \< 50 ml/minute. * Auto immune hepatitis or a history of autoimmune disease. * Severe hepatic dysfunction or decompensated cirrhosis of the liver. * Pre-existing thyroid disease unless it can be controlled with conventional treatment. * Epilepsy and/or compromised central nervous system (CNS) function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment | Week-48 | Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin. |
| Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up | Week-24 follow-up | Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin. |
| Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment | Week-24 | Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin. |
| Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up | Week-24 follow-up | Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment | Week-24 | Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment. |
| Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up | Week-24 follow-up | — |
| Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment | Week-48 | — |
| Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up | Week-24 follow-up | — |
| Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire | Week 12 | Participants will complete a single questionnaire during the first follow-up visit (Week 12). The questionnaire will measure the participant's satisfaction and the use of training materials for the PegIntron Pen during the course of study therapy, as measured by the participant using a 1- 5 score system provided in the questionnaire. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Genotype 1 CHC Participants and Non-genotype 1 CHC partipants | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment Indonesia | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up
Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Time frame: Week-24 follow-up
Population: The study was terminated early due to low enrollment. This analysis was not performed.
Primary
Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment
Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Time frame: Week-48
Population: The study was terminated early due to low enrollment. This analysis was not performed.
Primary
Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment
Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Time frame: Week-24
Population: The study was terminated early due to low enrollment. This analysis was not performed.
Primary
Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up
Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Time frame: Week-24 follow-up
Population: The study was terminated early due to low enrollment. This analysis was not performed.
Secondary
Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up
Time frame: Week-24 follow-up
Population: The study was terminated early due to low enrollment. This analysis was not performed.
Secondary
Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment
Time frame: Week-48
Population: The study was terminated early due to low enrollment. This analysis was not performed.
Secondary
Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up
Time frame: Week-24 follow-up
Population: The study was terminated early due to low enrollment. This analysis was not performed.
Secondary
Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment
Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.
Time frame: Week-24
Population: The study was terminated early due to low enrollment. This analysis was not performed.
Secondary
Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire
Participants will complete a single questionnaire during the first follow-up visit (Week 12). The questionnaire will measure the participant's satisfaction and the use of training materials for the PegIntron Pen during the course of study therapy, as measured by the participant using a 1- 5 score system provided in the questionnaire.
Time frame: Week 12
Population: The study was terminated early due to low enrollment. This analysis was not performed.