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

NCT ID: NCT00351871

Last Updated: 2009-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2007-11-30

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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

PEG-Intron Plus REBETOL

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: lead

Principal Investigators

William M. Cassidy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center

Other Identifiers

P03851

Identifier Type: -

Identifier Source: org_study_id