Phase 4
Completed N=6,661
A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00922779 ↗
Enrolled (actual)
6,661
Serious AEs
1.0%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) — 2058; 67 Participants
Summary
This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight ( 75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) |
2058; 67 | — |
| SECONDARY Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy |
50.9 | — |
| SECONDARY Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation |
58.8; 69.7; 24.8 | — |
| SECONDARY Percentage of Participants With Change in Hemoglobin Level |
13.5; 32.4; 11.7; 32.3; 10.0; 27.9 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- serological evidence of chronic hepatitis C;
- detectable serum HCV-RNA;
- liver biopsy findings consistent with a diagnosis of chronic hepatitis C.
Exclusion Criteria
- history or other evidence of a medical condition associated with chronic liver disease other than HCV;
- co-infection with active hepatitis A or B;
- hepatocellular carcinoma;
- patients with severe cardiovascular disease whose condition may worsen due to acute anemia.
Data sourced from ClinicalTrials.gov (NCT00922779). 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.