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Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)

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ClinicalTrials.gov Identifier: NCT00255008
Recruitment Status : Terminated (Slow enrollment)
First Posted : November 17, 2005
Results First Posted : January 6, 2010
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Biological: peginterferon alfa-2b Drug: ribavirin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SEASON South East Asian Study Of Novel Genotypes in Hepatitis C Infection: Pegylated-Interferon and Ribavirin Therapy (PEGATRON REDIPEN Combination Therapy (PEG-Intron® REDIPEN Plus REBETOL®)) in Treatment Naive Patients With Genotypes 1, 6, 7, 8, 9: A Comparison of Race and Genotype on Treatment Outcome.
Study Start Date : March 2005
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Genotype 1 SEA PEG-IFN/RIB 48 w
Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PEG-Intron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
Biological: peginterferon alfa-2b
Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
Other Name: SCH 54031, PegIntron REDIPEN
Drug: ribavirin
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks
Other Name: SCH 18908, REBETOL
Active Comparator: Genotype 1 Caucasian PEG-IFN/RIB 48 w
Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Biological: peginterferon alfa-2b
Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
Other Name: SCH 54031, PegIntron REDIPEN
Drug: ribavirin
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks
Other Name: SCH 18908, REBETOL
Experimental: Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Biological: peginterferon alfa-2b
Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks
Other Name: SCH 54031, PegIntron REDIPEN
Drug: ribavirin
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks
Other Name: SCH 18908, REBETOL
Active Comparator: Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Biological: peginterferon alfa-2b
Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
Other Name: SCH 54031, PegIntron REDIPEN
Drug: ribavirin
200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks
Other Name: SCH 18908, REBETOL


Outcome Measures

Primary Outcome Measures :
  1. Number of Subjects Who Achieved a Sustained Virologic Response (SVR) [ Time Frame: 24 weeks after completion of either up to 24 or 48 weeks of therapy ]
    SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Comply with all current Australian Schedule of Pharmaceutical Benefits S100 eligibility criteria.
  • Able to give written informed consent and adhere to study visit schedule.
  • South East Asian ethnicity (except for Caucasian Gt1/1b in comparator arm) i.e. born in Vietnam, Cambodia, Laos, Thailand, Hong Kong, and China or have both parents born in these countries.
  • Genotype 1, 1a, 1b, 6, 6a, 6b, 7, 8, or 9, as classified by INNO-LiPA assay.
  • Hemoglobin >=120 g/L (females), >=130 g/L (males).
  • Platelet count >=100 x 10^9/L.
  • Neutrophil count >=1.5 x 10^9/L.
  • Negative pregnancy test for females.
  • Thyroid stimulating hormone (TSH) within normal limits.

Exclusion Criteria:

  • Participation in any other investigational drug program within 30 days of the Screening Visit.
  • Human immunodeficiency virus (HIV) antibody positive or hepatitis B surface antigen (HBsAg) positive.
  • Genotype 2, 3, 4, or 5, as classified by INNO-LiPA assay.
  • Non South East Asian ethnicity (unless recruited to Caucasian GT1 comparator arm).
  • Evidence of liver disease due to other disorders (e.g., hemachromatosis, Wilson's disease).
  • Ongoing drug or alcohol abuse which in the opinion of the investigator would jeopardize the patient's ability to comply with study requirements.
  • Inability to comply with study requirements for other reasons.
  • Decompensated cirrhosis (Ascites, history of encephalopathy or bleeding varices, serum albumin <35 g/L, prothrombin time (PT) prolonged by greater than 3 sec).
  • Present or prior history of severe psychiatric disease requiring hospitalization or medication.
  • History of severe seizure disorder.
  • History of autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, immune thrombocytopenic purpura, systemic lupus erythematosus, or other mixed connective tissue disease, psoriasis, optic neuritis).
  • Poorly controlled thyroid disease.
  • Creatinine clearance <50 mL/min.
  • Severe cardiovascular disease.
  • Hepatocellular cancer.
  • Clinically significant ophthalmologic disorders.
  • Hemoglobinopathies (e.g., thalassemia, sickle-cell anemia).
  • Treatment or recent treatment with immunosuppressive agents (excluding short-term corticosteroid withdrawal), and immunosuppressed transplant recipients scheme.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00255008     History of Changes
Other Study ID Numbers: P04212
First Posted: November 17, 2005    Key Record Dates
Results First Posted: January 6, 2010
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Keywords provided by Merck Sharp & Dohme Corp.:
chronic hepatitis C
pegylated interferon alfa-2b
ribavirin
Asia

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs