Trials / Terminated
TerminatedNCT00686881
Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 261 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 . |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2011-02-01
- Completion
- 2011-02-01
- First posted
- 2008-05-30
- Last updated
- 2017-04-06
- Results posted
- 2012-03-06
Source: ClinicalTrials.gov record NCT00686881. Inclusion in this directory is not an endorsement.