Study the Relationship Between Obesity and Hepatitis C Replication

Withdrawn before enrolling · Phase 2

Conditions studied: Hepatitis C

In brief

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. .

Key facts

Study ID

NCT01157975

Run by

University of California, San Diego

People needed

0

Starts

2008-10-01

Expected to finish

2014-09-01

Last updated by the study team

2019-12-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California at San Diego Hospitals — San Diego, California, United States
• Agouza Hospital — Giza, Egypt

Full record on ClinicalTrials.gov

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