Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
This study has been terminated.
(This study was terminated due to low enrollment)
Merck Sharp & Dohme Corp.
First Posted: May 30, 2008
Last Update Posted: April 6, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Hepatitis C, Chronic||Biological: Peginterferon alfa-2b (PegIFN-2b) Drug: Comparator: Stronger neo minophagen C (SNMC)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Number of Participants With Change in Metavir Fibrosis Score [ Time Frame: Baseline and discontinuation of treatment (up to 156 weeks) ]Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).
Secondary Outcome Measures:
- Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration [ Time Frame: Week 24 ]The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.
- Number of Participants With Change in Metavir Inflammation Score [ Time Frame: Baseline and Week 48 ]Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).
|Study Start Date:||December 2006|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
Biological: Peginterferon alfa-2b (PegIFN-2b)
PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks
Active Comparator: SNMC
Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 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 .
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