Status:
TERMINATED
Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty Liver
Lead Sponsor:
Beth Israel Medical Center
Conditions:
Chronic Hepatitis C Infection
Fatty Liver
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
Brief Summary
To study the effectiveness and safety of adding Rosiglitazone, an insulin sensitizing agent to people with chronic hepatitis C infection genotype 1 with fatty liver disease, who are being treated with...
Detailed Description
Eligible thirty subjects will be randomized in a double blinded fashion to either Rosiglitazone 4mg pills twice a day versus placebo for six weeks. Then after this six week period, both groups will be...
Eligibility Criteria
Inclusion
- Men and women at least 21 years of age.
- Positive serum hepatitis C RNA for at least 6 months.
- Naive to any therapy for hepatitis C infection.
- Significant steatosis or fat on the liver biopsy.
- Genotype 1 patients.
Exclusion
- Subjects with decompensated liver disease.
- Hemoglobin \<12g/dl.
- WBC\<2,000mm3.
- ANC\<1,000mm3.
- Platelet count\<50,000/mm3.
- Creatinine\>1.5mg/dl.
- Albumin\<2.5g/dl.
- Bilirubin\>4mg/dl.
- HIV or hepatitis B co-infection.
- History of other liver disease besides fatty liver disease.
- History of unstable cardiac or cerebrovascular disease.
- History of significant psychiatric disorders.
- Alcohol or drug abuse within last year.
- Pregnant or lactating women or men whose sexual partner is pregnant or lactating.
- Taking of insulin or oral hypoglycemic agents within six months of the study.
- Uncontrolled thyroid disorder.
- History of malignancy within the past 5 years unless cured by surgery.
- History of autoimmune disorder or organ transplantations requiring immunosuppression.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00274495
Start Date
January 1 2006
End Date
October 1 2007
Last Update
November 1 2007
Active Locations (1)
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1
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, United States, 10003