Hepatitis C, Chronic
Conditions
Brief summary
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
Interventions
DRUGCOPEGUS
COPEGUS 800 mg or 1000-1200 mg po for 24 weeks
DRUGpeginterferon alfa-2a [Pegasys]
PEGASYS 180 micrograms sc once weekly for 24 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
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, genotype 1, 2, 3 * Compensated liver disease * Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders
Exclusion criteria
* Decompensated liver disease * Signs or symptoms of hepatocellular carcinoma * Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End of Treatment Response Rate at Week 72 in Genotype 1 | Week 72 | End of treatment response rate at Week 72 was reported for genotype 1. |
| End of Treatment Response in Genotype 2 and 3 | Week 48 | End of treatment response rate at Week 48 was reported for genotype 2 and 3. |
| Sustained Viral Response (SVR) Rates in CHC Genotype 1 | Week 96 | Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1. |
| SVR Rates in Genotype 2 and 3. | Week 72 | Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Event (AE) | Week 96 | 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. |
Countries
Israel
Participant flow
Recruitment details
Participants from Study NCT01429792 with genotype 1 Chronic Hepatitis C (CHC) and were 'Slow Responders' were eligible to enroll in this treatment extension study. Participants from Study NCT01429792 with genotype 2 and 3 CHC and were non-Rapid Virologic Response (RVR) were eligible to enroll in this treatment extension study.
Pre-assignment details
A total of 59 participants were enrolled in the study and 47 of them completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Pegylated Interferon (Peginterferon) Alfa-2a Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Positive HCV-RNA at week 48 | 1 |
| Overall Study | Unknown disposition | 1 |
| Overall Study | Withdrawal by Subject | 4 |
| Overall Study | Withdrew due to other reasons | 3 |
Baseline characteristics
| Characteristic | Pegylated Interferon (Peginterferon) Alfa-2a |
|---|---|
| Age, Continuous | 47.9 Years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 59 |
| serious Total, serious adverse events | 5 / 59 |
Outcome results
Primary
End of Treatment Response in Genotype 2 and 3
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Time frame: Week 48
Population: Participants with CHC Genotype 2 and 3 at Week 48.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHC Genotype 1 | End of Treatment Response in Genotype 2 and 3 | 66.7 Percentage of Participants |
Primary
End of Treatment Response Rate at Week 72 in Genotype 1
End of treatment response rate at Week 72 was reported for genotype 1.
Time frame: Week 72
Population: Participants with genotype 1 CHC at Week 72.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHC Genotype 1 | End of Treatment Response Rate at Week 72 in Genotype 1 | 68.2 Percentage of Participants |
Primary
Sustained Viral Response (SVR) Rates in CHC Genotype 1
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
Time frame: Week 96
Population: Participants with CHC genotype 1 at Week 96
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHC Genotype 1 | Sustained Viral Response (SVR) Rates in CHC Genotype 1 | 46.5 Percentage of participants |
Primary
SVR Rates in Genotype 2 and 3.
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
Time frame: Week 72
Population: Participants with CHC Genotype 2 \& 3 at week 72.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHC Genotype 1 | SVR Rates in Genotype 2 and 3. | 60.0 Percentage of participants |
Secondary
Percentage of Participants With Adverse Event (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: Week 96
Population: All enrolled participants were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHC Genotype 1 | Percentage of Participants With Adverse Event (AE) | 40.7 Percentage of Participants |