Hepatitis C Clinical Trial
— HCVNASHOfficial title:
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
Verified date | February 2012 |
Source | Brooke Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | Ft. Sam Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center | Hoffmann-La Roche, The Geneva Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Hepatic steatosis, necroinflammatory activity and fibrosis improvement at week 36 as determined by Dr. Elizabeth Brunt at Saint Louis University | 36 weeks | No |
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