Status:
COMPLETED
Infergen, Ribavirin & Avandia in Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin
Lead Sponsor:
Brooke Army Medical Center
Collaborating Sponsors:
InterMune
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during treatment) or relapsed (virus went away on treatment but came back after treatment was stopped) after treatme...
Detailed Description
This study will demonstrate the efficacy of treating insulin resistance with rosiglitazone in CHC, genotype 1 patients who have failed previous treatment with pegylated interferon and ribavirin. Pre-t...
Eligibility Criteria
Inclusion
- Participants willing to give written informed consent and able to adhere to dose and visit schedules.
- Adult participants 18 years of age or older of either gender or any race. Participants who are over 65 years of age must be in generally good health.
- HCV-antibody (Ab) or HCV-RNA positive by polymerase chain reaction (PCR) for at least 6 months.
- Serum positive for HCV-RNA by PCR assay.
- Subjects must be previous nonresponders or relapsers on pegylated interferon and ribavirin therapy.
- Liver biopsy within 24 months prior to enrollment into the protocol.
- Compensated liver disease with the following minimum hematological, biochemical, and serologic criteria at the Screening Visit (WNL = within normal limits):
- Hemoglobin values of \< 12 gm/dL for females and \< 13 gm/dL for males.
- White blood cells (WBC) \< 3,000/mm3
- Neutrophil count \< 1,500/mm3
- Platelets \< 65,000/mm3
- Direct bilirubin, within 20% of upper limits of normal (ULN)
- Indirect bilirubin, (WNL) (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise. In such cases indirect bilirubin must be \< 3.0 mg/dL \[\< 51.3 µmol/L\]).
- Albumin \> 3 gm/dL
- Serum creatinine \< 20% of ULN
- Thyroid stimulating hormone (TSH) WNL
- Alpha fetoprotein value \< 100 ng/mL.
- Reconfirmation and documentation that sexually active female subjects of childbearing potential are practicing adequate contraception during the treatment period and for 6 months following the last dose of study medication. Female subjects must not be breast-feeding.
- Reconfirmation that sexually active male subjects are practicing two acceptable methods of contraception during the treatment period and for 6 months following the last dose of study medication.
Exclusion
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Participants on insulin are excluded.
- Participants on metformin or another thiazolidinedione must have a three-month wash-out period to be considered for the study.
- Women who are pregnant or breast-feeding
- Males whose female partner is pregnant
- No other thiazolidinedione after liver biopsy and/or during the entire study (other than those subjects randomized to receive rosiglitazone during the study)
- Hepatitis C of non-genotype 1
- Suspected hypersensitivity to interferon, ribavirin, or rosiglitazone
- Any cause for liver disease other than chronic hepatitis C, insulin resistance, or non-alcoholic fatty liver disease (NAFLD), including but not limited to:
- Hemochromatosis
- Alpha-1 antitrypsin deficiency
- Co-infection with hepatitis B virus (HBV) \[serum hepatitis B surface antigen (HBsAg) positive\]
- Wilson's disease
- Autoimmune hepatitis
- Alcoholic liver disease (consumption of greater than 2 drinks a day on average)
- Drug-related liver disease
- Any condition that would prevent the subject from having a liver biopsy.
- Hemoglobinopathies that could potentially compromise patient safety (e.g., beta thalassemia major, sickle cell disease)
- Evidence of advanced liver disease
- Participants with organ transplants other than cornea and hair transplant
- Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:
- Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt.
- Participants with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject's mental status supports that the participant is clinically stable.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00207402
Start Date
October 1 2005
End Date
July 1 2010
Last Update
February 14 2012
Active Locations (1)
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1
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234