Study the Relationship Between Obesity and Hepatitis C Replication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157975
Recruitment Status : Unknown
Verified November 2011 by Mario Chojkier, University of California, San Diego.
Recruitment status was:  Active, not recruiting
First Posted : July 8, 2010
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):
Mario Chojkier, 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. .

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Pioglitazone Drug: Prednisone 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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.
Study Start Date : October 2008
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pioglitazone Drug: Pioglitazone
Pioglitazone will be taken at a dose of 30 mg for up to 14 days
Other Name: ACTOS
Experimental: Prednisone Drug: Prednisone
Prednisone will be taken at a dose of 40 mg for up to 4 days

Primary Outcome Measures :
  1. HCV RNA [ Time Frame: 2 weeks ]
    Only in the Pioglitazone group

Secondary Outcome Measures :
  1. HCV RNA [ Time Frame: 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. [ Time Frame: Day 14 (Pioglitazone) and Day 4 (Prednisone) ]
  3. ALT and AST [ Time Frame: Day 14 (Pioglitazone) and Day 4 (Prednisone) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01157975

United States, California
University of California at San Diego Hospitals
San Diego, California, United States, 92037
Agouza Hospital
Giza, Egypt
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Mario Chojkier, MD UCSD
Principal Investigator: Martina Buck, PhD UCSD
Principal Investigator: Hesham Elkhayat, MD Cairo University, Egypt

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mario Chojkier, Professor of Medicine, University of California, San Diego Identifier: NCT01157975     History of Changes
Other Study ID Numbers: 060913
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: November 2011

Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hypoglycemic Agents