Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatments pioglitazone, prednisone
Phase phase 2
Sponsor University of California, San Diego
Start date October 2008
End date February 2014
Trial size 40 participants
Trial identifier NCT01157975, 060913

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 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. .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
pioglitazone ACTOS
Pioglitazone will be taken at a dose of 30 mg for up to 14 days
(Experimental)
prednisone PREDNISONE
Prednisone will be taken at a dose of 40 mg for up to 4 days

Primary Outcomes

Measure
HCV RNA
time frame: 2 weeks

Secondary Outcomes

Measure
HCV RNA
time frame: Day 4
Serum indicators of insulin resistance (fasting glucose, insulin, lipids and serum retinol binding protein-4); adiponectins and inflammatory cytokines.
time frame: Day 14 (Pioglitazone) and Day 4 (Prednisone)
ALT and AST
time frame: Day 14 (Pioglitazone) and Day 4 (Prednisone)

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Randomized, Partially Blinded, Pilot Study of the Effects of Pioglitazone on HCV RNA in Overweight Subjects With Chronic HCV Genotypes 1 or 4 Infection.
Principal investigator Mario Chojkier, MD
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 Genotype 4 started in Agouza Hospital in July 2010 and ended in February, 2011. No recruitment has occurred for HCV Genotype 1.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by University of California, San Diego.