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Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron (peginterferon alfa-2b; SCH 54031)
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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules. Males and non-pregnant females and aged >= 18 years, subjects who are over 65 years of age must be in generally good health and must be discussed with and approved by the principal investigator prior to entry. The laboratory evaluation within 6 months prior to entering the Pilot Treatment Program must meet the following criteria: Hemoglobin values of >= 12 g/dL for females and >= 13 g/dL for males Neutrophil count >= 1.5 X10^9/L Platelets count >= 100 x 10^9/L Total bilirubin < 1.5 mg/dL Serum creatinine within normal limits Positive serum HCV-RNA (>= 50 IU (100 copy numbers)/mL) Anti-HCV positive Available HCV genotype 1 Liver biopsy performed within 12 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (METAVIR system >=F1). Compensated liver disease with the following hematological, biochemical, and serologic criteria at the screening visit: Hemoglobin values of >= 9 g/dL Neutrophil count >= 0.75 x 10^9/L Platelets count >= 50 x 10^9/L Prothrombin time (PT) prolong <= 3 sec, International Normalized Ratio (INR) <= 1.2 Total bilirubin <= 3 mg/dL Within normal limits (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met). Anti-Human Immunodeficiency Virus (HIV) negative. Alpha-fetoprotein (AFP) value within normal limits obtained within 12 months prior to entry. Results above the upper limit of normal but <= 50 ng/mL require both of the following: AFP value <= 50 ng/mL obtained within 9 months prior to entry in the study or during the Screening period, and Ultrasound obtained within 9 months prior to entry or in the screening period in the study for evidence of not having hepatocellular carcinoma. A urine pregnancy test obtained prior to the initiation of pilot treatment must be negative. Female subjects must not be breast feeding. Reconfirmation that sexually-active subjects are practicing acceptable methods of contraception during screening period. Complete 24 weeks treatment of the Pilot Treatment Program with Peg-Intron + Ribavirin. Must be never treated with interferon for HCV infected hepatitis (treatment naïve) before the Pilot Treatment Program. The total amount of Peg-Intron and Ribavirin received during the pilot treatment program must achieve more than 80% of the recommended dosage. Exclusion Criteria: Women who are pregnant or nursing. Have decompensated cirrhosis. History of severe psychiatric disease, especially depression. Concurrent malignancies (including hepatocellular carcinoma). Unstable or significant cardiovascular diseases. Subjects with (ECG) showing clinically significant abnormalities. Prolonged exposure to known hepatotoxins such as alcohol or drugs. History of thyroid disease poorly controlled on prescribed medication. Poorly controlled diabetes mellitus. Has suspected or confirmed significant hepatic disease from an etiology other than HCV. Patients co-infected with hepatitis B and /or human immunodeficiency virus (HIV). Severe renal disease or myeloid dysfunction. History of organ transplantation other than cornea and hair transplant. Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids. Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol. Allergy to interferon.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    24-Week Treatment

    48-Week Treatment

    Arm Description

    Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)

    Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)

    Outcomes

    Primary Outcome Measures

    The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)
    Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy

    Secondary Outcome Measures

    The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.
    Virologic response was defined as undetectable HCV-RNA level in the blood.

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    March 8, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00202839
    Brief Title
    Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)
    Official Title
    Comparison of the Sustained Response of Peg-Intron/Ribavirin Combination Therapy in Genotype 1-Infected Hepatitis C Patients for Non-extended Versus 24-week Extended Treatment After 24 Weeks Pilot Treatment in Taiwan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    July 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 open-label, randomized, comparative, multicenter, 48-week study designed to evaluate the efficacy and safety of combination treatment with pegylated interferon and ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24 weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects will be randomly assigned to one of two study groups. One group will be followed for an additional 48 weeks without study medication, while the other will be continuously treated for an additional 24 weeks and then followed for another 24 weeks without study medication. Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the follow-up period, will be measured along with other outcomes.
    Detailed Description
    This is an open-label, randomized, comparative, multicenter study for evaluation of PegIntron/Ribavirin therapy in the efficacy and safety in adult subjects with a diagnosis of compensated chronic hepatitis C (HCV-RNA+) (Genotype 1). This is a 48-week study, for which all subjects should participate in the Pilot Treatment Program and complete 24 weeks treatment. To avoid a treatment gap, subjects who will be screened and eligible subjects will sign informed consent prior to the end of the Pilot Treatment Program. After completion of the Pilot Treatment Program, all eligible subjects will be randomly assigned to either study group. Subjects in the 24-Week Treatment arm will be followed-up without study medication for 48 weeks; subjects in the 48-Week Treatment arm will be continuously treated for another 24 weeks and all subjects in the 48-Week Treatment arm will be followed for another 24 weeks after completion of the treatment period. Subjects in both arms will be evaluated at screening, randomization, 4, 8, 12, 16, 20, 24, 28, 36 and 48 weeks after randomization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    24-Week Treatment
    Arm Type
    Experimental
    Arm Description
    Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
    Arm Title
    48-Week Treatment
    Arm Type
    Active Comparator
    Arm Description
    Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
    Intervention Type
    Biological
    Intervention Name(s)
    PegIntron (peginterferon alfa-2b; SCH 54031)
    Other Intervention Name(s)
    peginterferon alfa-2b; SCH 54031
    Intervention Description
    Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program
    Intervention Type
    Biological
    Intervention Name(s)
    PegIntron (peginterferon alfa-2b; SCH 54031)
    Other Intervention Name(s)
    peginterferon alfa-2b; SCH 54031
    Intervention Description
    Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program followed by 1.2 to 1.5 microgram/kg weekly for 24 weeks during the extended treatment program
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Other Intervention Name(s)
    SCH 18908
    Intervention Description
    200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Other Intervention Name(s)
    SCH 18908
    Intervention Description
    200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program and for 24 weeks during the extended treatment program
    Primary Outcome Measure Information:
    Title
    The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)
    Description
    Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy
    Time Frame
    24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy
    Secondary Outcome Measure Information:
    Title
    The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.
    Description
    Virologic response was defined as undetectable HCV-RNA level in the blood.
    Time Frame
    48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules. Males and non-pregnant females and aged >= 18 years, subjects who are over 65 years of age must be in generally good health and must be discussed with and approved by the principal investigator prior to entry. The laboratory evaluation within 6 months prior to entering the Pilot Treatment Program must meet the following criteria: Hemoglobin values of >= 12 g/dL for females and >= 13 g/dL for males Neutrophil count >= 1.5 X10^9/L Platelets count >= 100 x 10^9/L Total bilirubin < 1.5 mg/dL Serum creatinine within normal limits Positive serum HCV-RNA (>= 50 IU (100 copy numbers)/mL) Anti-HCV positive Available HCV genotype 1 Liver biopsy performed within 12 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (METAVIR system >=F1). Compensated liver disease with the following hematological, biochemical, and serologic criteria at the screening visit: Hemoglobin values of >= 9 g/dL Neutrophil count >= 0.75 x 10^9/L Platelets count >= 50 x 10^9/L Prothrombin time (PT) prolong <= 3 sec, International Normalized Ratio (INR) <= 1.2 Total bilirubin <= 3 mg/dL Within normal limits (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met). Anti-Human Immunodeficiency Virus (HIV) negative. Alpha-fetoprotein (AFP) value within normal limits obtained within 12 months prior to entry. Results above the upper limit of normal but <= 50 ng/mL require both of the following: AFP value <= 50 ng/mL obtained within 9 months prior to entry in the study or during the Screening period, and Ultrasound obtained within 9 months prior to entry or in the screening period in the study for evidence of not having hepatocellular carcinoma. A urine pregnancy test obtained prior to the initiation of pilot treatment must be negative. Female subjects must not be breast feeding. Reconfirmation that sexually-active subjects are practicing acceptable methods of contraception during screening period. Complete 24 weeks treatment of the Pilot Treatment Program with Peg-Intron + Ribavirin. Must be never treated with interferon for HCV infected hepatitis (treatment naïve) before the Pilot Treatment Program. The total amount of Peg-Intron and Ribavirin received during the pilot treatment program must achieve more than 80% of the recommended dosage. Exclusion Criteria: Women who are pregnant or nursing. Have decompensated cirrhosis. History of severe psychiatric disease, especially depression. Concurrent malignancies (including hepatocellular carcinoma). Unstable or significant cardiovascular diseases. Subjects with (ECG) showing clinically significant abnormalities. Prolonged exposure to known hepatotoxins such as alcohol or drugs. History of thyroid disease poorly controlled on prescribed medication. Poorly controlled diabetes mellitus. Has suspected or confirmed significant hepatic disease from an etiology other than HCV. Patients co-infected with hepatitis B and /or human immunodeficiency virus (HIV). Severe renal disease or myeloid dysfunction. History of organ transplantation other than cornea and hair transplant. Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids. Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol. Allergy to interferon.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ding-Shinn Chen, MD
    Organizational Affiliation
    Investigational Site
    Official's Role
    Study Chair

    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

    Learn more about this trial

    Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)

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