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

Primary Purpose

Chronic Hepatitis C Infection, Fatty Liver

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rosiglitazone and Pegasys/Ribavirin
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Genotype 1, Metabolic syndrome, Insulin resistance

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Uncontrolled thyroid disorder. History of malignancy within the past 5 years unless cured by surgery. History of autoimmune disorder or organ transplantations requiring immunosuppression.

Sites / Locations

  • Beth Israel Medical Center - Philipps Ambulatory Care Center

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
January 9, 2006
Last Updated
October 31, 2007
Sponsor
Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00274495
Brief Title
Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty Liver
Official Title
Randomized Placebo-Control Pilot Study Evaluating the Efficacy and Safety of Rosiglitazone Combined With Pegylated Interferon Plus Ribavirin Versus Pegylated Interferon Plus Ribavirin Alone in Genotype 1 Hepatitis C With Steatosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Beth Israel Medical Center

4. Oversight

5. Study Description

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.
Detailed Description
Eligible thirty subjects will be randomized in a double blinded fashion to either Rosiglitazone 4mg pills twice a day versus placebo for six weeks. Then after this six week period, both groups will be treated for 48 weeks of standard therapy for hepatitis C consisting of Pegasys 180mcq weekly injections with Ribavirin 1,000mg-1,200mg daily depending if the subject weights less than 75 kg will then receive the lower dosage. In addition, the subjects will be continued on Rosiglitazone or placebo for the 48 weeks. The subjects will be monitored for side-effects by history taking and blood testing at predetermined time periods during the study. If the viral load has not dropped more than two log at week 12 of standard therapy for hepatitis C then therapy will be stopped and the subject is considered a treatment failure. Similarly, if there was a greater than two log drop in the viral load at week 12 but there is still virus present in the blood at week 24 then therapy is stopped and the subject is considered treatment failure. If the virus is undetectable in the blood at week 12 and 24 then therapy is continued for the full 48 weeks. If the virus is detectable at week 48 then the subject is considered a treatment failure. After this 48 week treatment period and the virus is still undetectable, there is a follow-up period consisting of 24 weeks off therapy. At the end of the 24 weeks, blood will be tested for the virus and if the virus is not present then the subject has a sustained viral response and is a treatment success. During therapy if the subject becomes significantly anemic Procrit 40,000Units weekly injections will be started. Similarly, if the white blood cell count drops below a certain level then weekly Neupogen 300mcq injections will be started. In addition, if there is mild depressive symptoms treatment will be started but if there is major depressive symptoms, then therapy will be stopped and a referral to a psychiatrist will be made.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection, Fatty Liver
Keywords
Genotype 1, Metabolic syndrome, Insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosiglitazone and Pegasys/Ribavirin
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Uncontrolled thyroid disorder. History of malignancy within the past 5 years unless cured by surgery. History of autoimmune disorder or organ transplantations requiring immunosuppression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Meyer, M.D.
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry C. Bodenheimer, M.D.
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Beth Israel Medical Center - Philipps Ambulatory Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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