Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy
This study has been completed.
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Collaborator:
Schering-Plough
Information provided by:
Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT00351871
First received: July 12, 2006
Last updated: February 3, 2009
Last verified: February 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Influence of Marker of Insulin Resistance Upon HCV Treatment Responses to PEG Intron and Rebetol Therapy |
Resource links provided by NLM:
Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:
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.
| Enrollment: | 400 |
| Study Start Date: | April 2002 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
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 |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00351871 History of Changes |
| Other Study ID Numbers: | P03851 |
| Study First Received: | July 12, 2006 |
| Last Updated: | February 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
|
HCV |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Insulin Resistance Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Reaferon Interferon Alfa-2b Ribavirin Peginterferon alfa-2b Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013