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Infergen, Ribavirin & Avandia in Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin

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ClinicalTrials.gov Identifier: NCT00207402
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 14, 2012
Sponsor:
Collaborator:
InterMune
Information provided by (Responsible Party):
Stephen A Harrison, Brooke Army Medical Center

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date February 14, 2012
Study Start Date  ICMJE October 2005
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
There is change in viral kinetics with improvement of insulin sensitivity [ Time Frame: 104 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
There is change in viral kinetics with improvement of insulin sensitivity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
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 [ Time Frame: 72 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Infergen, Ribavirin & Avandia in Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin
Official Title  ICMJE A Pilot Trial of Combination Therapy With Interferon Alfacon1, Ribavirin, & Rosiglitazone in a Group of Insulin Resistant, Chronic Hepatitis C, GT 1 Patients Who Are Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin
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 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, affects the HCV viral 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE Drug: rosiglitazone
Infergen 15mcg/ d Avandia qd Ribavirin bid
Other Names:
  • Infergen (interferon alfacon-1)
  • Avandia (rosiglitazone)
  • Ribavirin
Study Arms  ICMJE
  • Active Comparator: rosiglitazone
    Treatment with rosiglitazone 4 mg twice a day for 3 months prior to and during the course of 48 weeks of treatment with interferon alfacon-1 15mcg/0.5ml SQ daily and weight-based ribavirin.
    Intervention: Drug: rosiglitazone
  • No Intervention: No Avandia
    Monitoring period without rosiglitazone for 3 months prior to 48 weeks of interferon alfacon-1 15mcg/0.5ml SQ daily and weight-based ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2009)
34
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
40
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00207402
Other Study ID Numbers  ICMJE C2005.143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen A Harrison, Brooke Army Medical Center
Study Sponsor  ICMJE Brooke Army Medical Center
Collaborators  ICMJE InterMune
Investigators  ICMJE
Principal Investigator: Stephen A Harrison, MD Brooke Army Medical Center
Principal Investigator: Shane Mills, MD Brooke Army Medical Center
PRS Account Brooke Army Medical Center
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP