Status:
COMPLETED
Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Collaborating Sponsors:
Schering-Plough
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 Reb...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00351871
Start Date
April 1 2002
End Date
November 1 2007
Last Update
February 4 2009
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