Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685)
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|ClinicalTrials.gov Identifier: NCT00265395|
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : July 8, 2009
Last Update Posted : April 5, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to treatment.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Drug: Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) Drug: Combination of pegylated interferon alfa-2b and ribavirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1428 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Assess Treatment With PEG-Intron® and Rebetol® in Naïve Patients With Genotype 1 Chronic Hepatitis C and Slow Virological Response|
|Study Start Date :||December 2004|
|Primary Completion Date :||May 2008|
|Study Completion Date :||May 2008|
Active Comparator: Standard therapy
Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
Drug: Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®)
Experimental: Extended therapy
Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
Drug: Combination of pegylated interferon alfa-2b and ribavirin
Primary Outcome Measures :
- Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment. [ Time Frame: 48 or 72 weeks of treatment plus 24 weeks of follow-up. ]LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)
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