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

Completed · Phase 4 · Has a placebo group

Conditions studied: Fatty Liver, Hepatitis C

In brief

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.

Key facts

Study ID

NCT00207311

Run by

Brooke Army Medical Center

People needed

30

Starts

2005-08-01

Expected to finish

2009-05-01

Last updated by the study team

2012-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• TSH WNL
• Alpha fetoprotein value < 100 ng/mL
• Reconfirmation and documentation that sexually active female subjects of childbearing potential are practicing adequate contraception method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for six months following the last dose of study medication
• Reconfirmation that sexually active male subjects are practicing two acceptable methods of contraception

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
• Hemoglobinopathies (e.g., Beta Thalassemia)
• Evidence of advanced liver disease
• Patients with organ transplants other than cornea and hair transplant
• Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:
• Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded
• CNS trauma or preexisting/active seizure disorders uncontrolled with medication
• Significant cardiovascular dysfunction within the past 12 months
• Poorly controlled diabetes mellitus
• Chronic pulmonary disease with documented pulmonary hypertension
• Immunologically mediated disease (Crohn's disease, ulcerative colitis), rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis

Where it is running

• Brooke Army Medical Center — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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