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Trial record 42 of 382 for:    IFNA2 AND RBV AND genotype

Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00255034
Recruitment Status : Terminated (Recruitment targets were unachievable in the currently available population.)
First Posted : November 17, 2005
Results First Posted : July 23, 2009
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 15, 2005
First Posted Date  ICMJE November 17, 2005
Results First Submitted Date  ICMJE June 4, 2009
Results First Posted Date  ICMJE July 23, 2009
Last Update Posted Date April 6, 2017
Study Start Date  ICMJE February 2005
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2014)
Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy [ Time Frame: 24 weeks after completion of either up to 24 or 48 weeks of therapy ]
No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00255034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED)
Official Title  ICMJE Phase IV Study of Tailored Therapy With Peg Interferon Alfa 2b and Ribavirin for Patients With Genotype 3 and High Viral Load. Genotype 3 Extended Treatment for HCV (GET-C Study)
Brief Summary This is an Australian, open-label, multicenter, randomized, double-blind clinical trial designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at least F1A2). The primary endpoint will be a sustained virological response defined by undetectable HCV RNA in serum at 24 weeks after completion of therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: 24 weeks of therapy
    Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
    Interventions:
    • Biological: Peginterferon alfa-2b
    • Drug: Ribavirin
  • Experimental: 48 weeks of therapy
    Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
    Interventions:
    • Biological: Peginterferon alfa-2b
    • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 4, 2009)
146
Original Enrollment  ICMJE
 (submitted: November 15, 2005)
624
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Comply with all current Australian Schedule of Pharmaceutical Benefits S100 eligibility criteria.
  • Chronic hepatitis C genotype 3 infection with a viral load of at least 2 million copies per mL.
  • Able to give written informed consent.
  • Understand and be able to adhere to the dosing and visit schedules.
  • Compensated liver disease with the following minimum hematologic and biochemical criteria:

    • Hemoglobin ≥120 g/L (females), ≥130 g/L (males)
    • Platelets ≥100 x 10^9/L
    • Neutrophil count ≥1.5 x 10^9/L
    • Creatinine clearance >50 mL/minute
    • Thyroid stimulating hormone (TSH) within normal limits
  • Serum hepatitis B surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative.
  • Negative pregnancy test.

Exclusion Criteria:

  • Suspected hypersensitivity to interferon, pegylated interferon alfa-2b, or ribavirin.
  • Participation in any other investigational drug program within 30 days of the screening visit for this protocol.
  • Any cause of liver disease based on patient history and biopsy other than chronic hepatitis C, including but not limited to: hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, autoimmune hepatitis, alcoholic liver disease, drug-related liver disease.
  • Hepatocellular carcinoma.
  • Decompensated cirrhosis (ascites, history of encephalopathy or bleeding varices, serum albumin <35 g/L, prothrombin time (PT) prolonged by greater than 3 sec).
  • Significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, myocardial infarction, severe hypertension, or significant arrhythmia) or participants with an ECG showing clinically significant abnormalities.
  • Immunologically-mediated disease, (e.g. inflammatory bowel disease), idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis).
  • Hemophilia or any hemoglobinopathy, including but not limited to thalassemia major.
  • Severe psychiatric condition, including major depression, a history of major psychoses, current suicidal ideation, and/or suicidal attempts.
  • Ongoing substance abuse, e.g. alcohol, I.V. drugs or inhalants that in the opinion of the investigator would jeopardize the patient's ability to comply with study requirements.
  • Clinically significant ophthalmological disorders.
  • Treatment or recent treatment with immunosuppressive agents (excluding short-term corticosteroid withdrawal) and immunosuppressed transplant recipients.
  • Poorly controlled thyroid disease.
  • Any other condition that in the opinion of the investigator would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the clinical trial program.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   New Zealand
 
Administrative Information
NCT Number  ICMJE NCT00255034
Other Study ID Numbers  ICMJE P04143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

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