Status:
COMPLETED
Study for the Treatment of Significant Steatosis With Xenical Followed by Treatment of Hepatitis C With Pegasys/Copegus
Lead Sponsor:
Brooke Army Medical Center
Collaborating Sponsors:
Hoffmann-La Roche
The Geneva Foundation
Conditions:
Fatty Liver
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 hepatiti...
Detailed Description
Recent evidence suggests that patients with concomitant chronic HCV infection and NASH or significant hepatic steatosis (\>33%) respond less well to standard antiviral therapy. As previously noted, up...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00207311
Start Date
August 1 2005
End Date
May 1 2009
Last Update
February 14 2012
Active Locations (1)
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1
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234