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Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)

NCT00686881 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2017-04-06

Study results available
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Summary

The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2 and F3) who were previously treated with interferon. The trial will evaluate the effect of treatment on the progression of liver fibrosis, liver inflammation, and liver function. Treatment will be administered for up to 156 weeks with a 4-week follow-up.

Conditions

  • Hepatitis C, Chronic

Interventions

BIOLOGICAL

Peginterferon alfa-2b (PegIFN-2b)

PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks

DRUG

Comparator: Stronger neo minophagen C (SNMC)

SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2011-02-28
Completion
2011-02-28

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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 NCT00686881 on ClinicalTrials.gov