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

Primary Purpose

Hepatitis C, Chronic

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Peginterferon alfa-2b
Peginterferon alfa-2b
Ribavirin
Ribavirin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring chronic hepatitis C, pegylated interferon alfa-2b, ribavirin, Australia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    24 weeks of therapy

    48 weeks of therapy

    Arm Description

    Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks

    Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks

    Outcomes

    Primary Outcome Measures

    Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion 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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2005
    Last Updated
    March 8, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00255034
    Brief Title
    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
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Recruitment targets were unachievable in the currently available population.
    Study Start Date
    February 2005 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic
    Keywords
    chronic hepatitis C, pegylated interferon alfa-2b, ribavirin, Australia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    146 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    24 weeks of therapy
    Arm Type
    Active Comparator
    Arm Description
    Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
    Arm Title
    48 weeks of therapy
    Arm Type
    Experimental
    Arm Description
    Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
    Intervention Type
    Biological
    Intervention Name(s)
    Peginterferon alfa-2b
    Other Intervention Name(s)
    SCH 54031, PegIntron
    Intervention Description
    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
    Intervention Type
    Biological
    Intervention Name(s)
    Peginterferon alfa-2b
    Other Intervention Name(s)
    SCH 54031 PegIntron
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Other Intervention Name(s)
    SCH 18908 Rebetol
    Intervention Description
    200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Other Intervention Name(s)
    SCH 18908 Rebetol
    Intervention Description
    200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks
    Primary Outcome Measure Information:
    Title
    Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy
    Description
    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.
    Time Frame
    24 weeks after completion of either up to 24 or 48 weeks of therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

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    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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