Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181) (FAST-4)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT00723645

P05181

Details and patient eligibility

About

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.

Enrollment: 279 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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).

Trial design

279 participants in 1 patient group

PEG IFN alfa-2b + RBV

Description:

Adult participants with chronic hepatitis C who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment during this study.