Boceprevir in Subjects With Previously Untreated Chronic HCV Genotype 1

This study is currently recruiting participants.

Verified by Benaroya Research Institute, November 2008

Sponsors and Collaborators:	Benaroya Research Institute Schering-Plough
Information provided by:	Benaroya Research Institute
ClinicalTrials.gov Identifier:	NCT00795431

Purpose

This study aims to compare the standard treatment for chronic hepatitis C infection (PegIntron + Ribavirin) to the standard care plus boceprevir (a new protease inhibitor used to prevent viral replication). It is also designed to examine whether a shorter treatment period with boceprevir is effective in patients with undetectable virus load after 8 weeks of treatment.

Patients will undergo 4 weeks of treatment with PegIntron + Ribivirin and will then be given either boceprevir or placebo for an additional 44 weeks.

Condition	Intervention	Phase
Hepatitis C	Drug: Boceprevir Drug: Placebo	Phase III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Boceprevir

U.S. FDA Resources

Study Type:	Interventional
Official Title:	Boceprevir in Subjects With Previously Untreated Chronic HCV Genotype 1

Further study details as provided by Benaroya Research Institute:

Arms	Assigned Interventions
1: Experimental	Drug: Boceprevir Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Men and Women over the age of 18 with a documented diagnosis of chronic hepatitis C genotype 1 who have not received any treatment for their disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795431

Contacts

Contact: Cheryl Saunders

206-341-1786

cheryl.saunders@vmmc.org

Locations

United States, Washington
Benaroya Research Institute at Virginia Mason Medical Center	Recruiting
Seattle, Washington, United States, 98101
Contact: Cheryl Saunders 206-341-1786 cheryl.saunders@vmmc.org
Principal Investigator: Kris Kowdley

Sponsors and Collaborators

Benaroya Research Institute

Schering-Plough

More Information

Responsible Party:	Virginia Mason Medical Center ( Kris Kowdley )
Study ID Numbers:	IRB08066, 366
Study First Received:	November 19, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795431
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases

Digestive System Diseases
Hepatitis, Viral, Human
Hepatitis C

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 14, 2009