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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)(TERMINATED)

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00255008
First received: November 15, 2005
Last updated: December 2, 2009
Last verified: December 2009

November 15, 2005
December 2, 2009
March 2005
December 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00255008 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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)(TERMINATED)
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • 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
  • 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 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
    Interventions:
    • Biological: peginterferon alfa-2b
    • Drug: ribavirin
  • 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
    Interventions:
    • Biological: peginterferon alfa-2b
    • Drug: ribavirin
  • 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
    Interventions:
    • Biological: peginterferon alfa-2b
    • Drug: ribavirin
  • 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
    Interventions:
    • Biological: peginterferon alfa-2b
    • Drug: ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
121
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00255008
P04212
No
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Schering-Plough
Not Provided
Not Provided
Schering-Plough
December 2009

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