Study for the Treatment of Significant Steatosis With Xenical Followed by Treatment of Hepatitis C With Pegasys/Copegus
HCVNASH
A Multi-Centered, Prospective, Randomized, Placebo-Controlled Clinical Trial for the Treatment of Significant Steatosis or NASH With Xenical Followed by Treatment of Hepatitis C (HCV) With PEG-Interferon Alpha-2a/Copegus
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFebruary 14, 2012
February 1, 2012
3.8 years
September 13, 2005
February 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained virological response (SVR) defined as the percentage of participants with undetectable HCV-RNA as measured by the Roche AMPLICORTM HCV Test, v 2.0 (detection limit 50 IU/mL) at 24 weeks post completion of the treatment period
110 weeks
Secondary Outcomes (1)
Hepatic steatosis, necroinflammatory activity and fibrosis improvement at week 36 as determined by Dr. Elizabeth Brunt at Saint Louis University
36 weeks
Study Arms (2)
Xenical placebo
PLACEBO COMPARATORXenical placebo PO three times daily with meals plus enrollment into the Xenicare program for 36 weeks followed by 48 weeks of therapy with Pegasys (180mcg/ml) plus weight based ribavirin for HCV genotype 1 or 4 and 24 weeks of therapy with Pegasys (180mcg/ml) plus 800mg ribavirin for HCV genotypes 2 and 3.
Xenical (orlistat)
ACTIVE COMPARATORXenical (orlistat) 120mg PO three times daily with meals plus enrollment into the Xenicare program for 36 weeks followed by 48 weeks of therapy with Pegasys (180mcg/ml) plus weight based ribavirin for HCV genotype 1 or 4 and 24 weeks of therapy with Pegasys (180mcg/ml) plus 800mg ribavirin for HCV genotypes 2 and 3.
Interventions
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.
Xenicare program for 36 weeks.
Eligibility Criteria
You may qualify if:
- Participants must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- HCV-Ab or HCV-RNA by PCR Positive for at least 6 months
- Serum positive for HCV-RNA by PCR assay
- Treatment naïve participants who have hepatitis C with genotype 1, 2, 3, or 4
- Body mass index \>27
- Liver biopsy within 12 months with a pathology report confirming the histological diagnosis consistent with CHCand NASH or hepatic steatosis of \>33%
- Compensated liver disease with minimum hematological, biochemical, and serologic criteria at the Enrollment Visit (WNL = within normal limits):
- Hemoglobin values of \<12 gm/dL for females and \<13 gm/dL for males
- WBC \<3,000/ mm3
- Neutrophil count \< 1,500/mm3
- Platelets \<65,000/ mm3
- Direct bilirubin within 20% of ULN
- Indirect bilirubin WNL
- Albumin \> 3 gm/dL
- creatinine \< 20% of ULN
- +4 more criteria
You may not qualify if:
- Women who are pregnant or breast-feeding
- Males whose female partner is pregnant
- No other Thiazolidinedione after liver biopsy and/or during the entire study
- Hepatitis C of non-genotype 1,2,3 or 4
- Previous anti-viral therapy for treatment of Hepatitis C
- Suspected hypersensitivity to interferon, PEG-interferon, ribavirin, Xenical
- Any other cause for liver disease other than chronic hepatitis C and NASH or steatosis, including but not limited to:
- Hemochromatosis
- Alpha-1 antitrypsin deficiency
- Co-infection with HBV
- Wilson's disease
- Autoimmune hepatitis
- Alcoholic liver disease
- Drug-related liver disease
- Any condition that would prevent the subject from having a liver biopsy
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brooke Army Medical Centerlead
- Hoffmann-La Rochecollaborator
- The Geneva Foundationcollaborator
Study Sites (1)
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen A Harrison, MD
Brooke Army Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
August 1, 2005
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
February 14, 2012
Record last verified: 2012-02