Influence of Marker of Insulin Resistance Upon HCV Treatment Responses to PEG Intron and Rebetol Therapy - Full Text View

Sponsors and Collaborators:	Louisiana State University Schering-Plough
Information provided by:	Louisiana State University
ClinicalTrials.gov Identifier:	NCT00351871

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 IV

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Insulin Ribavirin Interferon alfa-2b Peginterferon Alfa-2b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Influence of Marker of Insulin Resistance Upon HCV Treatment Responses to PEG Intron and Rebetol Therapy

Further study details as provided by Louisiana State University:

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.

Estimated Enrollment:	400
Study Start Date:	April 2002
Estimated Study Completion Date:	November 2007

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351871

Sponsors and Collaborators

Louisiana State University

Schering-Plough

Investigators

Principal Investigator:

William M. Cassidy, M.D.

Louisiana State University Health Sciences Center

More Information

Study ID Numbers:	P03851
Study First Received:	July 12, 2006
Last Updated:	July 12, 2006
ClinicalTrials.gov Identifier:	NCT00351871
Health Authority:	United States: Institutional Review Board

Keywords provided by Louisiana State University:

HCV

Study placed in the following topic categories:

Liver Diseases
Metabolic Diseases
Hepatitis, Chronic
Ribavirin
Hepatitis, Viral, Human
Insulin
Hepatitis
Virus Diseases
Hyperinsulinism

Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder
Interferon Alfa-2b
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009