Phase 4
N=1,013
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01429792 ↗Enrolled (actual)
1,013
Serious AEs
4.9%
Results posted
Oct 2018
Primary outcome: Primary: Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment — 15.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- peginterferon alfa-2a [Pegasys] (Drug); ribavirin [Copegus] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment |
15.7 | — |
| PRIMARY Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment |
50.8 | — |
| PRIMARY Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24 |
15.6 | — |
| PRIMARY Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 |
48.03 | — |
| PRIMARY Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment |
51.97 | — |
| PRIMARY Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24 |
6.9 | — |
| SECONDARY Percentage of Participants With pEVR to Study Treatment at Week 12 |
— | — |
| SECONDARY Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment |
— | — |
| SECONDARY Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24 |
— | — |
Summary
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
- Documented pre-treatment HCV RNA quantitative result
- Compensated liver disease (Child-Pugh Grade A)
- Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)
Exclusion Criteria
- Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
- Co-infection with active hepatitis A and/or hepatitis B
- History or evidence of a medical condition associated with liver disease other than HCV
- Signs and symptoms of hepatocellular carcinoma
- History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
- Therapy with antineoplastic treatment </= 6 months prior to study day
- Diabetes mellitus in subjects receiving an insulin therapy
- Evidence of severe retinopathy
- Pregnant or breast-feeding women, and male partners of women who are pregnant
Data sourced from ClinicalTrials.gov (NCT01429792). 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.