Status:
COMPLETED
Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
Lead Sponsor:
St. Louis University
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Fatty Liver
Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinf...
Detailed Description
Previous studies have suggested that steady weight loss over time will result in improvement in aminotransferases, and more importantly, underlying histopathology in patients with NASH. A total of 50 ...
Eligibility Criteria
Inclusion
- Liver biopsy obtained no more than 24 months before randomization with a pathology report confirming that the histological diagnosis is consistent with NASH
- Compensated liver disease with the following laboratory parameters at the entry visit:
- Hemoglobin values of greater than or equal to 12 gm/dl for females or 13 gm/dl for males
- WBC count \> 3,000/mm3
- Neutrophil count \> 1,500/mm3
- Platelets \> 70,000/mm3
- Albumin \>3.0 g/dl
- Serum creatinine \<1.4mg/dl
- Ability to give informed consent
- Alanine aminotransferase (ALT) greater than or equal to 40 U/L
- BMI \> or equal to 27 kg/m2
- Patients who receive orlistat must agree to participate in Xenicare, a free dietary counseling program provided by Roche (sponsor)
Exclusion
- Any cause for chronic liver disease other than NASH
- Evidence of decompensated liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy
- History of alcohol consumption of greater than 20 grams per day in the past 2 years
- Prior surgical procedures to include gastroplasty, jejunoileal or jejunocolic bypass
- TPN within the past 6 months
- History of prior organ transplantation
- Concurrent enrollment in other experimental treatment protocols
- Use of ursodeoxycholic acid, rosiglitazone, pioglitazone, or metformin within the 6-month period before enrollment
- Women who are pregnant or breast-feeding
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00160407
Start Date
October 1 2003
End Date
December 1 2006
Last Update
November 20 2007
Active Locations (2)
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1
Saint Louis University
St Louis, Missouri, United States, 63110
2
Brooke Army Medical Center
San Antonio, Texas, United States, 78234