Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
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|ClinicalTrials.gov Identifier: NCT00686881|
Recruitment Status : Terminated (This study was terminated due to low enrollment)
First Posted : May 30, 2008
Results First Posted : March 6, 2012
Last Update Posted : April 6, 2017
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Biological: Peginterferon alfa-2b (PegIFN-2b) Drug: Comparator: Stronger neo minophagen C (SNMC)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
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 .
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).
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