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Study for the Treatment of Significant Steatosis With Xenical Followed by Treatment of Hepatitis C With Pegasys/Copegus

NCT00207311 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-02-14

No results posted yet for this study

Summary

This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with histological evidence of \> 33% hepatic steatosis or nonalcoholic steatohepatitis (NASH) and chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment naive) will be enrolled.

Conditions

Interventions

DRUG

Xenical, Pegasys, Copegus

Xenical 120mg three times daily for 36 weeks or xenical placebo (Arm 1). Pegasys 180 mcg weekly for 48 weeks. Ribavirin daily for 48 weeks.

BEHAVIORAL

Xenicare Program

Xenicare program for 36 weeks.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • The Geneva Foundation

    collaborator OTHER

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Stephen A Harrison, MD · Brooke Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00207311 on ClinicalTrials.gov