Phase 3
Completed N=626
Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)
Chronic Hepatitis C · Cirrhosis
Source: ClinicalTrials.gov NCT00048724 ↗
Enrolled (actual)
626
Serious AEs
26.7%
Results posted
Jun 2009
Primary outcomePrimary: Time to Observation of the First Clinical Event Experienced by a Subject — 3; 2; 5; 5 Participants — p=0.1439
Summary
The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Observation of the First Clinical Event Experienced by a Subject |
3; 2; 5; 5; 4; 4 | 0.1439 |
| SECONDARY Time to Observation of the Disease Progression Experienced by a Subject |
16; 17; 6; 6; 5; 7 | 0.0070 sig |
Eligibility Criteria
Inclusion Criteria
- Age at entry 18-65 years;
- Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
- Liver biopsy demonstrating cirrhosis
Exclusion Criteria
- Any other cause for liver disease other than chronic hepatitis C;
- History or presence of complications of cirrhosis;
- Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
- Diseases or conditions that could interfere with participation in the study
Data sourced from ClinicalTrials.gov (NCT00048724). 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.