Hepatitis C Antiviral Resistance in African-Americans

Phase 3

Completed

• Conditions: Hepatitis C
• Interventions: Drug: peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT00038974
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-06-05
• Study First Submitted QC: 2002-06-07
• Study First Posted: 2002-06-10
• Study Start: 2002-08
• Primary Completion: 2004-12
• Study Completion: 2005-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interferon and rivavirin	peginterferon alfa-2a	All patients received peginterferon alfa-2a in a dose of 180 μg weekly and ribavirin in a dose of 1000 (for patients with a body weight of ⩽75 kg) or 1200 mg (for those with a body weight of \>75 kg) daily.
Interferon and rivavirin	Ribavirin	All patients received peginterferon alfa-2a in a dose of 180 μg weekly and ribavirin in a dose of 1000 (for patients with a body weight of ⩽75 kg) or 1200 mg (for those with a body weight of \>75 kg) daily.

Primary Outcome Measures

Name	Time	Method
Sustained Virologic Response (SVR)	24 weeks after therapy is discontinued	The primary end point of therapy was an SVR that was definied as the absences of detectable HCV RNA in serum 24 weeks after therapy was stopped.

Trial Locations

Locations (8)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

Rush University; 🇺🇸 Chicago, Illinois, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

New York-Presbyterian Medical Center; 🇺🇸 New York, New York, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States