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

Influence of Marker of Insulin Resistance Upon HCV Treatment Responses to PEG Intron and Rebetol Therapy

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: PEG-Intron Plus 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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborators: Schering-Plough
• Investigators: Principal Investigator: William M. Cassidy, M.D., Louisiana State University Health Sciences Center

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: July 12, 2006
• First Submitted That Met QC Criteria: July 12, 2006
• First Posted (Estimate): July 13, 2006

Study Record Updates

• Last Update Posted (Estimate): February 4, 2009
• Last Update Submitted That Met QC Criteria: February 3, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: HCV
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hyperinsulinism; Hepatitis; Hepatitis A; Hepatitis C; Insulin Resistance; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin; Peginterferon alfa-2b
• Other Study ID Numbers: P03851

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No