Study the Relationship Between Obesity and Hepatitis C Replication
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|ClinicalTrials.gov Identifier: NCT01157975|
Recruitment Status : Withdrawn (Study was completed in another site)
First Posted : July 8, 2010
Last Update Posted : December 2, 2019
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. .
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Pioglitazone Drug: Prednisone||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||September 2014|
Pioglitazone will be taken at a dose of 30 mg for up to 14 days
Other Name: ACTOS
Prednisone will be taken at a dose of 40 mg for up to 4 days
- HCV RNA [ Time Frame: 2 weeks ]Only in the Pioglitazone group
- HCV RNA [ Time Frame: Day 4 ]Only in the Prednisone group
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157975
|United States, California|
|University of California at San Diego Hospitals|
|San Diego, California, United States, 92037|
|Principal Investigator:||Mario Chojkier, MD||UCSD|
|Principal Investigator:||Martina Buck, PhD||UCSD|
|Principal Investigator:||Hesham Elkhayat, MD||Cairo University, Egypt|