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Trial of Peg-interferon Plus Epoetin-alfa for Treatment of Chronic Hepatitis C Virus Infection

NCT00248339 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-03-20

No results posted yet for this study

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 ribavirin, thus increasing chances at lower viral levels and raising sustained virologic response.

Conditions

  • Hepatitis C

Interventions

DRUG

Peginterferon-alpha-2b (PEG-Intron)

PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week. PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.

DRUG

Ribavirin

PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week. PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.

DRUG

Epoetin-alpha (Procrit)

PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week. PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.

Sponsors & Collaborators

  • Ortho Biotech, Inc.

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Mitchell L. Shiffman, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2005-07-31
Completion
2005-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00248339 on ClinicalTrials.gov