Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

San Diego, California 92037


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.


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



Primary Contact:

Principal Investigator
Mario Chojkier, MD

Backup Contact:


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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.