Phase 4
Completed N=942
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00087646 ↗
Enrolled (actual)
942
Serious AEs
11.5%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants With Sustained Virological Response Rate — 52; 27 participants — p=0.0060
Summary
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Virological Response Rate |
52; 27 | 0.0060 sig |
| SECONDARY Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D) |
63; 49 | 0.9228 |
| SECONDARY Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D) |
74; 38 | 0.0006 sig |
| SECONDARY Percentage of Participants With Undetectable HCV-RNA |
24; 11; 32; 27; 32; 26 | <.0001 sig |
| SECONDARY Percentage of Participants With >=2log Drop in HCV-RNA |
62; 42; 51; 47 | <.0001 sig |
| SECONDARY Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D) |
-2.75; -2.18; -2.88; -2.64 | — |
| SECONDARY Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response |
51; 22; 41; 33 | — |
| SECONDARY Percentage of Participants With Relapse After End of Treatment |
49; 78; 59; 67 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- CHC infection;
- liver biopsy (in =12 weeks.
Exclusion Criteria
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection.
Data sourced from ClinicalTrials.gov (NCT00087646). 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.