Study the Relationship Between Obesity and Hepatitis C Replication
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Diego
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
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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
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 Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 23, 2013