Study of Response in Chronic Hepatitis C (CHC) Patients Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders (Study P04823AM3)(TERMINATED)
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Tracking Information | |
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First Received Date ICMJE | June 25, 2007 |
Last Updated Date | February 8, 2011 |
Start Date ICMJE | April 2007 |
Primary Completion Date | October 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Early Virological Response in Participants With and Without Insulin Resistance [ Time Frame: At Week 12 (after start of therapy) ] [ Designated as safety issue: No ] Early Virological Response (EVR) defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline in participants with and without insulin resistance. |
Original Primary Outcome Measures ICMJE |
Early Virological Response (EVR, defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline) in subjects with and without insulin resistance [ Time Frame: At Week 12 (after start of therapy) ] |
Change History | Complete list of historical versions of study NCT00493805 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
Sustained Virological Response (PCR 24 Weeks After End of Treatment) [ Time Frame: Up to 24 weeks following 48 or 72 weeks of therapy ] [ Designated as safety issue: No ] Sustained virological response (SVR) was defined as undetectable HCV RNA in serum at the end of follow-up (24 weeks after end of therapy) according to a polymerase chain reaction (PCR) assay. |
Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Study of Response in Chronic Hepatitis C (CHC) Patients Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders (Study P04823AM3)(TERMINATED) |
Official Title ICMJE | Study to Evaluate Response Rates in Chronic Hepatitis C (CHC) Patients Genotype 1 With Insulin Resistance and to Assess Prolonged Treatment Duration in Late Virological Responders |
Brief Summary | This is a Phase 3b/4, prospective, open-label, randomized, multicenter study of peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C, genotype 1. The study consists of two parts: (1) a noninterventional arm (HOMA IR <= 2) and (2) an interventional arm (HOMA IR > 2), where HOMA IR is the insulin resistance index for the participants calculated by fasting insulin (uU/mL) x [fasting glucose (mmol/L)/22.5]. Participants in the noninterventional arm are treated according to the European labeling and response rates are evaluated at Month 1 (optional), 3, 6, 12, and follow up. Participants in the interventional arm are treated with PEG-Intron 1.5 ug/kg (subcutaneous) once weekly plus weight-based REBETOL 800-1400 mg (oral capsules) daily for a variable period depending on their response at Week 12: (1) HCV-RNA positive with < 2-log drop in viral load, treatment will be discontinued; (2) HCV-RNA positive with >= 2-log drop in viral load; participants will be randomized (1:1) to Group A (stop treatment at Week 48) or Group B (stop treatment at Week 72); and (3) HCV-RNA negative, treatment will be changed to be according to the European labeling and response rates will be evaluated at Month 6, 12, and follow up. All participants will go on with their treatment after Week 12 until the results of the HCV polymerase chain reaction (PCR) are available (maximum of 4 weeks). |
Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 4 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |
* 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 |
Enrollment ICMJE | 59 |
Completion Date | October 2009 |
Primary Completion Date | October 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 65 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Administrative Information | |
NCT Number ICMJE | NCT00493805 |
Other Study ID Numbers ICMJE | P04823, EudraCT number:2006-000757-21 |
Has Data Monitoring Committee | No |
Responsible Party | Vice President of Late Stage Development, Merck Sharp and Dohme Corp |
Study Sponsor ICMJE | Schering-Plough |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Schering-Plough |
Verification Date | February 2011 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |