Status:
COMPLETED
Trial of Peg-interferon Plus Epoetin-alfa for Treatment of Chronic Hepatitis C Virus Infection
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if the use of epoetin-alpha will allow patients with chronic hepatitis C virus infection to be treated with higher doses of peginterferon-alpha-2b and ribavir...
Detailed Description
Chronic infection with hepatitis C virus (HCV) leads to cirrhosis, hepatocellular carcinoma and liver failure. The treatment for end stage liver disease is hepatic transplantation. It is therefore imp...
Eligibility Criteria
Inclusion
- HCV RNA positive in serum
- HCV genotype 1
- Liver histology consistent with chronic HCV performed within 24 months prior to starting medication in this study
Exclusion
- Previous interferon treatment
- Any other cause for liver disease
- Hemoglobin \>10 gm/dl
- WBC \>3,000/cubic mm
- Platelet count \> 80,000/cubic mm
- Serum albumin \< 3.5 gm.dl
- Conjugated serum bilirubin \> 2.0 mg/dl
- INR \> 1.5
- Positive HIV test
- Refusal to use adequate contraception in female subjects or the spouse.sexual partners of male subjects
- An elevation in TSH (thyroid stimulating hormone). Patients with a pre-existing thyroid disorder may enter the study if their TSH level can be maintained within the normal range.
- Women who are pregnant or breast feeding.
- A history of decompensated liver disease defined as presence of ascites, bleeding esophageal or gastric varices or hepatic encephalopathy.
- Patients with active alcohol/drug use.
- Patients with active psychiatric disorders which might be exacerbated by interferon therapy including schizophrenia and severe depression.
- Use of any immune suppressive medications within 3 months of starting interferon therapy.
- A history of cardiac disease to include recent myocardial infarction or angina.
- Patients with previous exposure to Procrit, Aranesp, GA\_EPO, or any other Epoetin formulations, within 6 months prior to enrollment in this study.
- Patients with known sensitivity to mammalian cell-derived products.
- Patients with known hypersensitivity to human albumin.
- Patients unable to provide informed consent.
- Any other medical condition which the primary investigator feels might be exacerbated or jeopardise the patient's participation in this study.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00248339
Start Date
May 1 2002
End Date
July 1 2005
Last Update
March 20 2017
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298