Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT00723645
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-29
• Primary Completion: 2010-04
• Study Completion: 2011-02
• Results First Submitted: 2012-03-23
• Results First Submitted QC: 2012-03-23
• Results First Posted: 2012-04-23
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-26
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

• Participants with chronic hepatitis C virus (HCV)[any genotype] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis C.
• Negative HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.

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Exclusion Criteria

• Women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. Appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner.
• Completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry.
• Positive HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
• Participants treated for a period shorter than the enrollment period.
• Co-infection with Human Immumodeficiency Virus (HIV).
• Co-infected with Hepatitis B Virus (HBV).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)	From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment	Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT.; RNA= Ribonucleic Acid

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)	From 24 weeks post-treatment to 72 weeks post-treatment	Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72.; SVR was defined as negative for HCV RNA at Week 24 of follow-up.