Study the Relationship Between Obesity and Hepatitis C Replication

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of California, San Diego.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Mario Chojkier, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01157975
First received: July 6, 2010
Last updated: February 11, 2013
Last verified: November 2011
  Purpose

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 Intervention Phase
Hepatitis C
Drug: Pioglitazone
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • HCV RNA [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Only in the Pioglitazone group


Secondary Outcome Measures:
  • HCV RNA [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
  • ALT and AST [ Time Frame: Day 14 (Pioglitazone) and Day 4 (Prednisone) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: PREDNISONE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157975

Locations
United States, California
University of California at San Diego Hospitals
San Diego, California, United States, 92037
Egypt
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
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mario Chojkier, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01157975     History of Changes
Other Study ID Numbers: 060913
Study First Received: July 6, 2010
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Prednisone
Pioglitazone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on September 16, 2014