The Effects of PegIntron Plus Rebetol in Subjects With Chronic Hepatitis C Not Responding to Pegasys (Study P03833)
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|ClinicalTrials.gov Identifier: NCT00441584|
Recruitment Status : Terminated (Subject accrual was prematurely terminated due slow enrollment.)
First Posted : March 1, 2007
Results First Posted : August 4, 2009
Last Update Posted : April 5, 2017
Merck Sharp & Dohme Corp.
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve sustained virological response (SVR) when treated with PegIntron plus Rebetol.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Biological: PegIntron (peginterferon alfa-2b) Drug: Rebetol (ribavirin)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of PEG-Intron Plus Rebetol in Subjects With Chronic Hepatitis C Genotype 1 Non Responder to Pegasys|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Experimental: PegIntron plus Rebetol
PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
Biological: PegIntron (peginterferon alfa-2b)
Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
Other Name: SCH 54031, PEG-Intron, PegIntron, ViraferonPeg, peginterferon alfa-2bDrug: Rebetol (ribavirin)
200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 48 weeks
Other Name: SCH 18908, Rebetol, REBETOL, ribavirin
Primary Outcome Measures :
- Number of Subjects Who Have Achieved Sustained Virological Response (SVR) at 24 Weeks Post End of Treatment [ Time Frame: Up to 48 weeks of treatment plus 24 weeks follow up ]Sustained virologic response is defined as a plasma HCV RNA level below Lower Level of Quantitation at 24 weeks post-treatment, which is < 30 IU/mL in this study.
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