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

March 16, 2017 updated by: Virginia Commonwealth University

An Open-label, Randomized Pilot Study to Compare the Effectiveness of Peginterferon-alfa-2b Plus Ribavirin to Peginterferon-alfa-2b Plus Epoetin-alfa and Two Doses of Ribavirin in the Treatment of Chronic Hepatitis C Virus Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 important the patients with chronic HCV infection be recognized and treated before they develop advanced disease. The most effective therapy for patients with chronic HCV appears to be the combination of peginterferon-alpha-2b (PEG-Intron) plus ribavirin. Overall, 54% of patients treated with these medications achieve sustained virologic response. Response to therapy is greatly enhanced in those patients who can tolerate this therapy and remain on treatment without the need for dose reduction. The single most common reason for reducing the dose of ribavirin is anemia. Ribavirin causes a dose dependent hemolytic anemia and this side effect is believed to be exacerbated by the marrow suppressive effects of interferon. Preliminary studies have suggested that anemia can be overcome with the use of erythropoetin. The present pilot study will test the hypothesis that treatment with Epoetin-alph will allow patients with chronic HCV to utilize higher doses of ribavirin along with PEG-Intron therapy and that this will lead to a more rapid decline in HCV RNA titer and an increase in sustained virologic response.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin ~13.3 mg/kg QD
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.
Active Comparator: 2
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.
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.
Active Comparator: 3
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean dose of ribavirin utilized in each of the 3 treatment arms will be compared.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients in each group who required a dose reduction of ribavirin
Time Frame: 18 months
18 months
Rate of virologic response and sustained virologic response observed in each group
Time Frame: 18 months
18 months
Rate of decline in HCV RNA titer in each group
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Ortho Biotech, Inc.

Investigators

  • Principal Investigator: Mitchell L. Shiffman, MD, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

November 2, 2005

First Submitted That Met QC Criteria

November 2, 2005

First Posted (Estimate)

November 3, 2005

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1988 WIRB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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