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

NCT00351871 | Completed Phase 4

• 1 other identifier: P03851
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Hepatitis C

Keywords

HCV

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

PEG-Intron Plus REBETOL DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Schering-Plough: collaborator

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• William M. Cassidy, M.D.

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 13, 2006
• Study Start: April 1, 2002
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 4, 2009

Record last verified: 2009-02