SCH 503034 Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659)(COMPLETED)

This study has been completed.

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00160251

Purpose

The primary objective of this study is to determine the safe and effective dose range of SCH 503034 in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus SCH 503034.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: SCH 503034	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferon alfa-2b Peginterferon Alfa-2b Boceprevir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C HCV-1 Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study

Further study details as provided by Schering-Plough:

Estimated Enrollment:	300
Study Start Date:	September 2005
Estimated Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key inclusion criteria:

Documented infection with chronic hepatitis C (CHC), genotype 1.
Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin.
No evidence of cirrhosis on liver biopsy.
Results of physical examination and laboratory tests within specified ranges.
Abstinence from use of abused substances.

Key exclusion criteria:

Women who are pregnant or nursing a child.
Patients with cirrhosis, co-infection with Hepatitis B or HIV, and African-American patients (by a protocol amendment, African-American patients can enroll at Sites 1-32).
Previous treatment with any HCV polymerase or protease inhibitor.
Patients who relapsed following response to previous treatment.
Evidence of advanced liver disease, or liver disease from a cause other than CHC.
Pre-existing psychiatric condition.

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	P03659
Study First Received:	September 8, 2005
Last Updated:	July 19, 2007
ClinicalTrials.gov Identifier:	NCT00160251
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

PEG-Intron
Ribavirin
Protease Inhibitor

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Signs and Symptoms
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Ribavirin
Peginterferon alfa-2b
Hepatitis, Viral, Human
Hepatitis C
Interferon Alfa-2b
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009