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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00351871
First Posted: July 13, 2006
Last Update Posted: February 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by:
Louisiana State University Health Sciences Center in New Orleans
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis C Drug: PEG-Intron Plus REBETOL Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Marker of Insulin Resistance Upon HCV Treatment Responses to PEG Intron and Rebetol Therapy

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

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.

Enrollment: 400
Study Start Date: April 2002
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351871


Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Schering-Plough
Investigators
Principal Investigator: William M. Cassidy, M.D. Louisiana State University Health Sciences Center
  More Information

ClinicalTrials.gov Identifier: NCT00351871     History of Changes
Other Study ID Numbers: P03851
First Submitted: July 12, 2006
First Posted: July 13, 2006
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Insulin Resistance
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs