Phase 4
Completed N=380
A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01258101 ↗
Enrolled (actual)
380
Serious AEs
8.8%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment — 80.9; 78.2; 81.0; 61.5 Percentage of participants
◆ Published Evidence
Emerging
1citation · ~0 / year
Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial.
Summary
This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.
Linked Publications
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Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment |
80.9; 78.2; 81.0; 61.5 | — |
| PRIMARY Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48 |
7.1; 0.0; 0.0; 0.0; 92.9; 100 | — |
| SECONDARY Percentage of Participants With Virological Response at the End of the Treatment |
98.3; 97.3; 95.2; 100 | — |
| SECONDARY Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment |
0.0; 0.0; 66.7; 100; 92.9; 100 | — |
| SECONDARY Number of Participants With Any Adverse Events and Any Serious Adverse Events |
139; 138; 29; 45; 12; 18 | — |
| SECONDARY Median Hemoglobin Levels at End of Treatment |
123.00; 131.00; 129.50; 131.00; 124.00; 130.00 | — |
| SECONDARY Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48 |
87.8; 87.9; 76.7; 69.4; NA; NA | — |
| SECONDARY Mean FSS Scores at Baseline and Weeks 16, 24 and 48 |
3.5; 3.4; 4.9; 3.9; NA; NA | — |
| SECONDARY Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48 |
3.3; 3.4; 3.0; NA; 3.1; 3.3 | — |
| SECONDARY Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48 |
8.2; 5.4; 9.0; NA; 10.7; 8.8 | — |
| SECONDARY Time to Viral Response |
165.1; 165.0; 114.5; 122.8 | 0.2667 |
Eligibility Criteria
Inclusion Criteria
- Adult patients, 18-65 years of age
- Chronic hepatitis C, genotype 2 or 3
- Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
- Abdominal sonography within 3 months prior to study start
Exclusion Criteria
- Previous interferon and/or pegylated interferon and ribavirin therapy
- Liver cirrhosis, class B or C (Child-Pugh)
- Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug
- History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
- Decompensated liver disease
- Positive for HIV
Data sourced from ClinicalTrials.gov (NCT01258101) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.