Back to resultsStudy the Relationship Between Obesity and Hepatitis C Replication
Primary Purpose
Hepatitis C
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pioglitazone
Prednisone
Sponsored by
About this trial
This is an interventional other trial for Hepatitis C
Eligibility Criteria
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
Sites / Locations
- University of California at San Diego Hospitals
- Agouza Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pioglitazone
Prednisone
Arm Description
Outcomes
Primary Outcome Measures
HCV RNA
Only in the Pioglitazone group
Secondary Outcome Measures
HCV RNA
Only in the Prednisone group
Serum indicators of insulin resistance (fasting glucose, insulin, lipids and serum retinol binding protein-4); adiponectins and inflammatory cytokines.
ALT and AST
Full Information
NCT ID
NCT01157975
First Posted
July 6, 2010
Last Updated
November 27, 2019
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01157975
Brief Title
Study the Relationship Between Obesity and Hepatitis C Replication
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study was completed in another site
Study Start Date
October 2008 (Actual)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pioglitazone
Arm Type
Experimental
Arm Title
Prednisone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
ACTOS
Intervention Description
Pioglitazone will be taken at a dose of 30 mg for up to 14 days
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone will be taken at a dose of 40 mg for up to 4 days
Primary Outcome Measure Information:
Title
HCV RNA
Description
Only in the Pioglitazone group
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
HCV RNA
Description
Only in the Prednisone group
Time Frame
Day 4
Title
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)
Title
ALT and AST
Time Frame
Day 14 (Pioglitazone) and Day 4 (Prednisone)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Chojkier, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martina Buck, PhD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hesham Elkhayat, MD
Organizational Affiliation
Cairo University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Diego Hospitals
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Agouza Hospital
City
Giza
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
22412837
Citation
Chojkier M, Elkhayat H, Sabry D, Donohue M, Buck M. Pioglitazone decreases hepatitis C viral load in overweight, treatment naive, genotype 4 infected-patients: a pilot study. PLoS One. 2012;7(3):e31516. doi: 10.1371/journal.pone.0031516. Epub 2012 Mar 7.
Results Reference
derived
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Study the Relationship Between Obesity and Hepatitis C Replication
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