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Therapy With Infergen, Ribavirin, & Avandia in a Group of Insulin Resistant, Chronic Hepatitis C, Genotype 1 Patients Who Are Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin
This study is not yet open for participant recruitment.
Verified by Brooke Army Medical Center, September 2005
Sponsors and Collaborators: The Geneva Foundation
InterMune
Information provided by: Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT00207402
  Purpose

Genotype 1 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 treatment with at least twelve weeks of a pegylated (long-acting) interferon and ribavirin will be considered for this study. There are two purposes to this study. First, to determine how rosiglitazone, a medicine used to treat diabetes, effects the HCV virus load; and second, to determine if treatment of insulin resistance with rosiglitazone prior to therapy for HCV will improve sustained virologic response (loss of virus that continues beyond six months after completion of HCV therapy) to HCV therapy.


Condition Intervention Phase
Hepatitis C
Drug: Infergen, ribavirin, rosiglitazone
Phase IV

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Insulin Ribavirin Rosiglitazone Rosiglitazone Maleate Interferons Interferon alfacon-1
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Pilot Trial of Combination Therapy With Interferon Alfacon-1, Ribavirin, and Rosiglitazone in a Group of Insulin Resistant, Chronic Hepatitis C, Genotype 1 Patients Who Are Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • There is change in viral kinetics with improvement of insulin sensitivity.

Secondary Outcome Measures:
  • There is significant improvement in the SVR obtained when treating insulin resistant patients with the insulin sensitizing medication, Avandia, prior to and during treatment with Infergen and ribavirin when compared to Infergen

Estimated Enrollment: 40
Study Start Date: October 2005
Estimated Study Completion Date: March 2008
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-treatment with rosiglitazone may become the new standard of care prior to HCV therapy for those patients who are insulin resistant, increasing their chance for achieving an SVR on interferon alfacon-1 combination therapy and decreasing the morbidity and mortality associated with chronic hepatitis C.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants willing to give written informed consent and be 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-Ab or HCV-RNA by PCR Positive for at least 6 months
  • Serum positive for HCV-RNA by PCR assay
  • Subjects must be a previous nonresponder or relapser on pegylated interferon and ribavirin therapy
  • Liver biopsy within 24 months prior to enrollment to 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 & <13 gm/dL for males.
    • WBC <3,000/ mm3
    • Neutrophil count < 1,500/mm3
    • Platelets <65,000/ mm3
    • Direct bilirubin, within 20% of (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 >3gm/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 Criteria:

  • 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 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 are excluded. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207402

Contacts
Contact: Stephen A Harrison, MD 210-916-5553
Contact: Karol Barstow, BSN RN CCRC 210-916-5553 karol.barstow@amedd.army.mil

Locations
United States, Texas
Brooke Army Medical Center
Ft. Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
The Geneva Foundation
InterMune
Investigators
Principal Investigator: Shane Mills, MD Brooke Army Medical Center
  More Information

Study ID Numbers: C2005.143
Study First Received: September 13, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00207402  
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Hepatitis C
Insulin resistance

Study placed in the following topic categories:
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Insulin
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Insulin Resistance
Interferon alfacon-1
Hepatitis C, Chronic
Rosiglitazone

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009