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

NCT00723645 | Completed Results

• 1 other identifier: P05181
• Study Type: observational
• Target: 279
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)

  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

  From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment

Secondary Outcomes (1)

• Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)

  From 24 weeks post-treatment to 72 weeks post-treatment

Study Arms (1)

PEG IFN alfa-2b + RBV

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with chronic hepatitis C who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President,Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: February 1, 2011
• Last Updated: November 30, 2015
• Results First Posted: April 23, 2012

Record last verified: 2015-11