Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty Liver

NCT00274495 | Terminated Phase 4

• 1 other identifier: 098-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effectiveness and safety of adding Rosiglitazone, an insulin sensitizing agent to people with chronic hepatitis C infection genotype 1 with fatty liver disease, who are being treated with standard therapy. Standard therapy consists of weekly pegylated interferon injections and daily ribavirin pills, whose dosage is weight based. This regimen in genotype 1 patients is effective in only 45% of patients at best. In addition, this therapy must be given for 48 weeks to be effective and has alot of side-effects. One risk factor for a poor response is fatty liver. Rosiglitazone has been shown to be effective in the treatment of patients with fatty liver alone. This study hopes to show that the addition of Rosiglitazone to the standard therapy in genotype 1 patients with fatty liver disease will increase effectiveness of the standard therapy of hepatitis C.

Conditions

Chronic Hepatitis C Infection; Fatty Liver

Keywords

Genotype 1; Metabolic syndrome; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy of Rosiglitazone in combination with pegylated interferon alfa-2a and ribavirin (weight-based) to that of pegylated interferon alfa-2a and ribavirin alone in terms of sustained viral response.

Secondary Outcomes (1)

• To compare the safety and tolerability of Rosiglitazone in combination with pegylated interferon-2a and ribavirin to that of pegylated interferon alfa-2a and ribavirin alone in terms of adverse events.

Interventions

Rosiglitazone and Pegasys/Ribavirin DRUG

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women at least 21 years of age.
• Positive serum hepatitis C RNA for at least 6 months.
• Naive to any therapy for hepatitis C infection.
• Significant steatosis or fat on the liver biopsy.
• Genotype 1 patients.

You may not qualify if:

• Subjects with decompensated liver disease.
• Hemoglobin \<12g/dl.
• WBC\<2,000mm3.
• ANC\<1,000mm3.
• Platelet count\<50,000/mm3.
• Creatinine\>1.5mg/dl.
• Albumin\<2.5g/dl.
• Bilirubin\>4mg/dl.
• HIV or hepatitis B co-infection.
• History of other liver disease besides fatty liver disease.
• History of unstable cardiac or cerebrovascular disease.
• History of significant psychiatric disorders.
• Alcohol or drug abuse within last year.
• Pregnant or lactating women or men whose sexual partner is pregnant or lactating.
• Taking of insulin or oral hypoglycemic agents within six months of the study.

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Israel Medical Center - Philipps Ambulatory Care Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Fatty Liver; Metabolic Syndrome; Insulin Resistance

Interventions

Rosiglitazone; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Douglas Meyer, M.D.

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

• Henry C. Bodenheimer, M.D.

  Beth Israel Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 11, 2006
• Study Start: January 1, 2006
• Study Completion: October 1, 2007
• Last Updated: November 1, 2007

Record last verified: 2006-01

Locations

US (1)