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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brooke Army Medical Center
• Collaborators: Hoffmann-La Roche; The Geneva Foundation
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Orlistat; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Any medical condition requiring, or likely to require chronic systemic administration of steroids

• Evidence of an active or suspected cancer or a history of malignancy where the risk of reoccurrence is ≥ 20% within 2 years

• Active clinical gout

• Substance abuse

• Participants not willing to be counseled/abstain from alcohol

• Participants with clinically severe retinal abnormalities

• Any other condition that in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the protocol

• Known positive HIV

• Inability/unwillingness to provide informed consent or abide by the requirements of the study