Study the Relationship Between Obesity and Hepatitis C Replication

Hepatitis C Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01157975
• Other study ID #: 060913
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: September 2014

Study information

• Verified date: November 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Pioglitazone
Pioglitazone will be taken at a dose of 30 mg for up to 14 days
• Prednisone
Prednisone will be taken at a dose of 40 mg for up to 4 days

Locations

Country	Name	City	State
Egypt	Agouza Hospital	Giza
United States	University of California at San Diego Hospitals	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Countries where clinical trial is conducted

United States,  Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV RNA	Only in the Pioglitazone group	2 weeks
Secondary	HCV RNA	Only in the Prednisone group	Day 4
Secondary	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)
Secondary	ALT and AST		Day 14 (Pioglitazone) and Day 4 (Prednisone)