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Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pegylated interferon alfa-2b
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

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with acute hepatitis C virus (HCV).
  • Normal and Elevated serum alanine transferase (ALT) levels
  • Positive serum HCV-RNA.
  • Aged between 18 and 65 years.
  • Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion

Exclusion Criteria:

  • Liver disease unrelated to HCV infection
  • Hemoglobin (Hgb) <12g/dL in women and <13g/dL in men; white blood cells (WBC) <3,000/uL; platelets (PLTs) <100,000/ul
  • Women with ongoing pregnancy or who are breast feeding
  • History of severe psychiatric disease, especially depression
  • History of neurologic disease, especially epilepsy
  • History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
  • Positive anti-Human Immunodeficiency Virus (HIV) antibodies
  • Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (>1/80)
  • Positive Hepatitis B surface antigen (HBsAg)
  • History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
  • History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    PEG-IFN 24

    PEG-IFN 12

    PEG-IFN + RVB 12

    Arm Description

    pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks

    pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks

    pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks

    Outcomes

    Primary Outcome Measures

    Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
    SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.

    Secondary Outcome Measures

    Virologic Response at the End of Treatment Follow-up (ETR)
    ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks treatment (depending on treatment arm) was <15 IU/mL.
    Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).
    LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.
    Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization
    ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.
    Number of Participants With Rapid Virologic Response (RVR)
    Participants were considered to have RVR if serum HCV RNA level at 2 or 4 weeks of treatment was below the cut off value of the referring local laboratory of each participating site.
    Number of Peripheral Blood Mononuclear Cells (PBMCs)
    Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.

    Full Information

    First Posted
    May 27, 2008
    Last Updated
    March 8, 2017
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Bioikos Ambiente Srl
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00686517
    Brief Title
    Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
    Official Title
    An Open, Randomized, Multicentre Trial to Evaluate Efficacy and Safety of a 24-week Course of PEG-Interferon Alpha-2b Versus a 12-week Course of PEG-Interferon Alpha-2b Alone or Plus Ribavirin in Patients With Acute Hepatitis C
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Bioikos Ambiente Srl

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PEG-IFN 24
    Arm Type
    Experimental
    Arm Description
    pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
    Arm Title
    PEG-IFN 12
    Arm Type
    Experimental
    Arm Description
    pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
    Arm Title
    PEG-IFN + RVB 12
    Arm Type
    Experimental
    Arm Description
    pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
    Intervention Type
    Biological
    Intervention Name(s)
    Pegylated interferon alfa-2b
    Other Intervention Name(s)
    SCH 54031, PegIntron
    Intervention Description
    1.5 ug/kg/week SC for 12 or 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Other Intervention Name(s)
    SCH 18908, Rebetol
    Intervention Description
    Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
    Primary Outcome Measure Information:
    Title
    Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
    Description
    SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.
    Time Frame
    Evaluated at the end of 6 months
    Secondary Outcome Measure Information:
    Title
    Virologic Response at the End of Treatment Follow-up (ETR)
    Description
    ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks treatment (depending on treatment arm) was <15 IU/mL.
    Time Frame
    At the end of treatment (either 12 weeks or 24 weeks depending on randomization).
    Title
    Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).
    Description
    LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.
    Time Frame
    At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).
    Title
    Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization
    Description
    ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.
    Time Frame
    Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.
    Title
    Number of Participants With Rapid Virologic Response (RVR)
    Description
    Participants were considered to have RVR if serum HCV RNA level at 2 or 4 weeks of treatment was below the cut off value of the referring local laboratory of each participating site.
    Time Frame
    Evaluated at 2 and 4 weeks of treatment
    Title
    Number of Peripheral Blood Mononuclear Cells (PBMCs)
    Description
    Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.
    Time Frame
    Treatment Weeks 2, 4, 8, and 12

    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: Diagnosed with acute hepatitis C virus (HCV). Normal and Elevated serum alanine transferase (ALT) levels Positive serum HCV-RNA. Aged between 18 and 65 years. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion Exclusion Criteria: Liver disease unrelated to HCV infection Hemoglobin (Hgb) <12g/dL in women and <13g/dL in men; white blood cells (WBC) <3,000/uL; platelets (PLTs) <100,000/ul Women with ongoing pregnancy or who are breast feeding History of severe psychiatric disease, especially depression History of neurologic disease, especially epilepsy History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease Positive anti-Human Immunodeficiency Virus (HIV) antibodies Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (>1/80) Positive Hepatitis B surface antigen (HBsAg) History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)

    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
    Citations:
    PubMed Identifier
    24442928
    Citation
    Santantonio T, Fasano M, Sagnelli E, Tundo P, Babudieri S, Fabris P, Toti M, Di Perri G, Marino N, Pizzigallo E, Angarano G; Acute Hepatitis C Study Group. Acute hepatitis C: a 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin. Hepatology. 2014 Jun;59(6):2101-9. doi: 10.1002/hep.26991. Epub 2014 Apr 29.
    Results Reference
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    Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

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