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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248339
First Posted: November 3, 2005
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University
November 2, 2005
November 3, 2005
March 20, 2017
May 2002
July 2005   (Final data collection date for primary outcome measure)
The mean dose of ribavirin utilized in each of the 3 treatment arms will be compared. [ Time Frame: 18 months ]
The mean dose of ribavirin utilized in each of the 3 treatment arms will be compared.
Complete list of historical versions of study NCT00248339 on ClinicalTrials.gov Archive Site
  • Number of patients in each group who required a dose reduction of ribavirin [ Time Frame: 18 months ]
  • Rate of virologic response and sustained virologic response observed in each group [ Time Frame: 18 months ]
  • Rate of decline in HCV RNA titer in each group [ Time Frame: 18 months ]
  • Number of patients in each group who required a dose reduction of ribavirin
  • Rate of virologic response and sustained virologic response observed in each group
  • Rate of decline in HCV RNA titer in each group
Not Provided
Not Provided
 
Trial of Peg-interferon Plus Epoetin-alfa for Treatment of Chronic Hepatitis C Virus Infection
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis C
  • 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: 1
    PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin ~13.3 mg/kg QD
    Interventions:
    • Drug: Peginterferon-alpha-2b (PEG-Intron)
    • Drug: Ribavirin
  • 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.
    Interventions:
    • Drug: Peginterferon-alpha-2b (PEG-Intron)
    • Drug: Ribavirin
    • Drug: Epoetin-alpha (Procrit)
  • 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.
    Interventions:
    • Drug: Peginterferon-alpha-2b (PEG-Intron)
    • Drug: Ribavirin
    • Drug: Epoetin-alpha (Procrit)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2005
July 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00248339
1988 WIRB
Yes
Not Provided
Not Provided
Virginia Commonwealth University
Virginia Commonwealth University
Ortho Biotech, Inc.
Principal Investigator: Mitchell L. Shiffman, MD Virginia Commonwealth University
Virginia Commonwealth University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP