Expired Study
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San Diego, California 92037


Purpose:

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 resistance in replicon cell culture systems. PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity. Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase HCV viral kinetics. .


Study summary:

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 Genotype 4 started in Agouza Hospital in July 2010 and ended in February, 2011. No recruitment has occurred for HCV Genotype 1.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT01157975


Primary Contact:

Principal Investigator
Mario Chojkier, MD
UCSD


Backup Contact:

N/A


Location Contact:

San Diego, California 92037
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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