Status:
WITHDRAWN
Study the Relationship Between Obesity and Hepatitis C Replication
Lead Sponsor:
University of California, San Diego
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2 are refractory to medical treatment. Also, HCV replication seems to be affected when modeling insulin resist...
Detailed Description
This is a randomized, two arm clinical trial. The investigators performing the primary and secondary endpoints are blinded to subject identifiers and arm identifiers. Subject's screening for HCV Geno...
Eligibility Criteria
Inclusion
- Infection with HCV genotype 1 or 4 (subjects infected with multiple genotypes are not eligible)
- BMI greater than 25 Kg/m2
- HCV-infected subjects naïve to treatment: subjects who either have never been treated for HCV infection or who previously received HCV treatment ending more than 3 months prior to enrollment for not longer than 2 weeks
- Plasma HCV RNA concentration of \>10,000 IU/mL at the screening evaluation
Exclusion
- Previous intolerance to Pioglitazone, Rosiglitazone, Troglitazone or corticosteroids
- Women who are pregnant or breastfeeding
- History of diabetes mellitus requiring treatment other than diet
- Decompensated liver disease or other known causes of liver disease including, but not limited to autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol- or drug-induced liver disease, or alpha-one antitrypsin deficiency
- Concurrent hepatitis B virus (HBV) infection
- Known immunodeficiency disease, autoimmune disorders or active gastrointestinal disease
- Abuse of alcohol or illicit drugs within 6 months before enrollment
- Use of an investigational drug within 4 weeks before the screening visit or during the screening period.
- Use of systemic immunosuppressants
- History of poorly controlled psychiatric disease or poorly controlled pulmonary disease
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01157975
Start Date
October 1 2008
End Date
September 1 2014
Last Update
December 2 2019
Active Locations (2)
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1
University of California at San Diego Hospitals
San Diego, California, United States, 92037
2
Agouza Hospital
Giza, Egypt