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
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Tracking Information | |||||
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First Submitted Date ICMJE | May 27, 2008 | ||||
First Posted Date ICMJE | May 30, 2008 | ||||
Results First Submitted Date | February 3, 2012 | ||||
Results First Posted Date | March 6, 2012 | ||||
Last Update Posted Date | April 6, 2017 | ||||
Study Start Date ICMJE | December 2006 | ||||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE |
Inhibition of liver fibrosis progression at the end of the treatment period [ Time Frame: At the end of the treatment period: (1) at Week 156 from the start of treatment; or (2) at discontinuation. ] | ||||
Change History | Complete list of historical versions of study NCT00686881 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773) | ||||
Official Title ICMJE | A Clinical Study of SCH 54031 as Monotherapy in IFN-treated Patients With Chronic Hepatitis C | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hepatitis C, Chronic | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
261 | ||||
Original Estimated Enrollment ICMJE |
500 | ||||
Actual Study Completion Date | February 2011 | ||||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | Japan | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00686881 | ||||
Other Study ID Numbers ICMJE | P04773 JPC-05-356-30 |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Merck Sharp & Dohme Corp. | ||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Merck Sharp & Dohme Corp. | ||||
Verification Date | March 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |