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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2005-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD

Group Type ACTIVE_COMPARATOR

Peginterferon-alpha-2b (PEG-Intron)

Intervention Type DRUG

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.

Ribavirin

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Peginterferon-alpha-2b (PEG-Intron)

Intervention Type DRUG

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.

Ribavirin

Intervention Type DRUG

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.

Epoetin-alpha (Procrit)

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Peginterferon-alpha-2b (PEG-Intron)

Intervention Type DRUG

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.

Ribavirin

Intervention Type DRUG

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.

Epoetin-alpha (Procrit)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No