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Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

NCT00048724 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 631

Last updated 2017-04-04

Study results available
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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.

Conditions

  • Chronic Hepatitis C
  • Cirrhosis

Interventions

BIOLOGICAL

peginterferon alfa-2b (SCH 54031)

0.5 µg/kg subcutaneously once weekly for 60 months

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2008-04-30
Completion
2008-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00048724 on ClinicalTrials.gov