Study the Relationship Between Obesity and Hepatitis C Replication

Phase 2

Withdrawn

• Conditions: Hepatitis C
• Interventions: Drug: Pioglitazone; Drug: Prednisone

• Registration Number: NCT01157975
• Lead Sponsor: University of California, San Diego

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 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. .

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

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-08
• Primary Completion: 2014-02
• Study Completion: 2014-09
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pioglitazone	Pioglitazone	-
Prednisone	Prednisone	-

Primary Outcome Measures

Name	Time	Method
HCV RNA	2 weeks	Only in the Pioglitazone group

Secondary Outcome Measures

Name	Time	Method
HCV RNA	Day 4	Only in the Prednisone group
ALT and AST	Day 14 (Pioglitazone) and Day 4 (Prednisone)
Serum indicators of insulin resistance (fasting glucose, insulin, lipids and serum retinol binding protein-4); adiponectins and inflammatory cytokines.	Day 14 (Pioglitazone) and Day 4 (Prednisone)

Trial Locations

Locations (2)

Agouza Hospital; 🇪🇬 Giza, Egypt

University of California at San Diego Hospitals; 🇺🇸 San Diego, California, United States