Trial of Peg-interferon Plus Epoetin-alfa for Treatment of Chronic Hepatitis C Virus Infection
Completed · Phase 3
Conditions studied: Hepatitis C
In brief
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 ribavirin, thus increasing chances at lower viral levels and raising sustained virologic response.
Key facts
- Study ID
- NCT00248339
- Run by
- Virginia Commonwealth University
- People needed
- 150
- Starts
- 2002-05-01
- Expected to finish
- 2005-07-01
- Last updated by the study team
- 2017-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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