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Study the Relationship Between Obesity and Hepatitis C Replication

Sponsor
University of California, San Diego (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01157975
Collaborator
(none)
0
Enrollment
2
Locations
2
Arms
71
Actual Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

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. .

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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 :
Oct 1, 2008
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pioglitazone

Drug: Pioglitazone
Pioglitazone will be taken at a dose of 30 mg for up to 14 days
Other Names:
  • ACTOS

    		•
    Experimental: Prednisone

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

    Outcome Measures

    Primary Outcome Measures

    1. HCV RNA [2 weeks]

      Only in the Pioglitazone group

    Secondary Outcome Measures

    1. HCV RNA [Day 4]

      Only in the Prednisone group

    2. 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)]

    3. ALT and AST [Day 14 (Pioglitazone) and Day 4 (Prednisone)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California at San Diego Hospitals San Diego California United States 92037
    2 Agouza Hospital Giza Egypt

    Sponsors and Collaborators

    • University of California, San Diego

    Investigators

    • Principal Investigator: Mario Chojkier, MD, UCSD
    • Principal Investigator: Martina Buck, PhD, UCSD
    • Principal Investigator: Hesham Elkhayat, MD, Cairo University, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mario Chojkier, Professor of Medicine, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT01157975
    Other Study ID Numbers:
    • 060913
    First Posted:
    Jul 8, 2010
    Last Update Posted:
    Dec 2, 2019
    Last Verified:
    Nov 1, 2019
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis
    Pioglitazone
    Prednisone

    Study Results

    No Results Posted as of Dec 2, 2019