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Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PEG-Intron Plus REBETOL
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Evidence of chronic hepatitis C infection (viremia) by RT-PCR superquantitative HCV Genotype 1 Liver biopsy within 36 months of enrollment consistent with chronic hepatitis Compensated liver disease with laboratory parameters at entry visit as follows: Hemoglobin values of > 12 gm/dL WBC > 2,500/mm3 Neutrophil count > 1,000/mm3 Platelets > 100,000/mm3 Prothrombin time < 2 seconds prolonged compared to control, or equivalent INR ratio Bilirubin within 20% of the upper limit of normal unless non-hepatitis related factors exists such as Gilbert's syndrome. Albumin > 3.0 g/dL Serum creatinine < 1.4 mg/dL Normal thyroid stimulating hormone (TSH) or thyroid disease clinically controlled Antinuclear antibodies (ANA)< 1:160 FBS < 126 mg/dl No significant co-existing psychiatric disease Free from substance abuse for past 2 years Exclusion Criteria: Previous treatment for HCV. Evidence of being HIV positive. Hypersensitivity to alpha interferon, Peg Intron or Rebetol. Any other causes for chronic liver disease other than chronic hepatitis C besides obesity. Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia. Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or hepatic encephalopathy. Preexisting medical condition that could interfere with the patient's participation in the protocol including: CNS trauma or active seizure disorders requiring medication; diabetes mellitus; serious pulmonary disease; immunologically mediated diseases; gout attack within 12 months; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids. Patients with evidence of ischemia on stress testing, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months. Patients with a history of organ transplantation will be excluded. Patients taking insulin sensitizing drugs.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Difference in treatment response rates between those with insulin resistance those without.

    Secondary Outcome Measures

    Which marker of Insulin Resistance (i.e. the HOMA score, Waste Circumference or BMI) is the best measure for risk of hypo responsiveness.

    Full Information

    First Posted
    July 12, 2006
    Last Updated
    February 3, 2009
    Sponsor
    Louisiana State University Health Sciences Center in New Orleans
    Collaborators
    Schering-Plough
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00351871
    Brief Title
    Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy
    Official Title
    Influence of Marker of Insulin Resistance Upon HCV Treatment Responses to PEG Intron and Rebetol Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    November 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Louisiana State University Health Sciences Center in New Orleans
    Collaborators
    Schering-Plough

    4. Oversight

    5. Study Description

    Brief Summary
    The objective of this study is to better understand the influence of insulin resistance upon treatment response in hepatitis C virus treated with PEG Intron and Rebetol.
    Detailed Description
    The relationship between HCV and IR is an evolving one. This study will allow a more formal evaluation of this relationship. Four hundred patients will be treated using weight based Peg Intron and Rebetol. Clinical and biochemical data related to IR will be collected to determine if any such factors can predict who will have a sustained virological response. To evaluate patients for insulin resistance, the HOMA score (the product of the fasting insulin level and blood glucose level), waist circumference, and body mass index will be measured.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C
    Keywords
    HCV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    PEG-Intron Plus REBETOL
    Primary Outcome Measure Information:
    Title
    Difference in treatment response rates between those with insulin resistance those without.
    Secondary Outcome Measure Information:
    Title
    Which marker of Insulin Resistance (i.e. the HOMA score, Waste Circumference or BMI) is the best measure for risk of hypo responsiveness.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Evidence of chronic hepatitis C infection (viremia) by RT-PCR superquantitative HCV Genotype 1 Liver biopsy within 36 months of enrollment consistent with chronic hepatitis Compensated liver disease with laboratory parameters at entry visit as follows: Hemoglobin values of > 12 gm/dL WBC > 2,500/mm3 Neutrophil count > 1,000/mm3 Platelets > 100,000/mm3 Prothrombin time < 2 seconds prolonged compared to control, or equivalent INR ratio Bilirubin within 20% of the upper limit of normal unless non-hepatitis related factors exists such as Gilbert's syndrome. Albumin > 3.0 g/dL Serum creatinine < 1.4 mg/dL Normal thyroid stimulating hormone (TSH) or thyroid disease clinically controlled Antinuclear antibodies (ANA)< 1:160 FBS < 126 mg/dl No significant co-existing psychiatric disease Free from substance abuse for past 2 years Exclusion Criteria: Previous treatment for HCV. Evidence of being HIV positive. Hypersensitivity to alpha interferon, Peg Intron or Rebetol. Any other causes for chronic liver disease other than chronic hepatitis C besides obesity. Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia. Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or hepatic encephalopathy. Preexisting medical condition that could interfere with the patient's participation in the protocol including: CNS trauma or active seizure disorders requiring medication; diabetes mellitus; serious pulmonary disease; immunologically mediated diseases; gout attack within 12 months; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids. Patients with evidence of ischemia on stress testing, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months. Patients with a history of organ transplantation will be excluded. Patients taking insulin sensitizing drugs.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William M. Cassidy, M.D.
    Organizational Affiliation
    Louisiana State University Health Sciences Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy

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