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A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Interferon-beta-1a
Placebo
Ribavirin plus Interferon-beta-1a
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Subjects with chronic hepatitis C who have never previously received interferon therapy.

Eligibility Criteria

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

Inclusion Criteria: Age between 18 and 65 years Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal Had adequate bone marrow reserve and organ function Are not pregnant and are willing to use contraception, if, of childbearing potential Are willing and able to comply with the protocol and to give written informed consent Other protocol defined inclusion criteria may apply Exclusion Criteria: Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures Any cause for the liver disease other than chronic hepatitis C Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody Previous systemic treatment for Hepatitis C with an interferon or ribavirin Presence of systemic disease that might interfere with subject safety, compliance or evaluation Known allergies to acetaminophen, human serum albumin or mannitol; Glucocorticosteroids or other immunosuppressive drugs taken within 28 days of starting treatment Bearing organ transplants (except cornea) Other protocol defined exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Interferon-beta-1a

    Ribavarin plus interferon-beta-1a

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of subjects achieving sustained viral response (SVR) at Week 24
    Percentage of subjects achieving sustained viral response (SVR) at Week 48

    Secondary Outcome Measures

    Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48
    Percentage of subjects with Alanine transaminase (ALT) normalization
    Percentage of subjects with viral clearance
    Percentage of subjects with both SVR and sustained ALT normalization
    Number of subjects with improvement in the liver necroinflammation score by at least two points
    Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point
    Number of subjects with adverse events and serious adverse events

    Full Information

    First Posted
    November 4, 2005
    Last Updated
    August 4, 2013
    Sponsor
    EMD Serono
    Collaborators
    Merck Pte. Ltd., Singapore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00249860
    Brief Title
    A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
    Official Title
    A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    August 2005 (Actual)
    Study Completion Date
    August 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMD Serono
    Collaborators
    Merck Pte. Ltd., Singapore

    4. Oversight

    5. Study Description

    Brief Summary
    The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy. This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment during an open-label extension phase. The duration of the trial will be 48 weeks, with a double-blind period of 12 weeks. The study will recruit 257 eligible subjects of either sex. It will be conducted by approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and Singapore).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C
    Keywords
    Subjects with chronic hepatitis C who have never previously received interferon therapy.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    257 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Interferon-beta-1a
    Arm Type
    Experimental
    Arm Title
    Ribavarin plus interferon-beta-1a
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Interferon-beta-1a
    Intervention Description
    Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin plus Interferon-beta-1a
    Intervention Description
    Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24
    Primary Outcome Measure Information:
    Title
    Percentage of subjects achieving sustained viral response (SVR) at Week 24
    Time Frame
    Week 24
    Title
    Percentage of subjects achieving sustained viral response (SVR) at Week 48
    Time Frame
    Week 48
    Secondary Outcome Measure Information:
    Title
    Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48
    Time Frame
    Baseline, Week 12, 24, and 48
    Title
    Percentage of subjects with Alanine transaminase (ALT) normalization
    Time Frame
    Week 12, 24, and 48
    Title
    Percentage of subjects with viral clearance
    Time Frame
    Week 12 and 24
    Title
    Percentage of subjects with both SVR and sustained ALT normalization
    Time Frame
    Week 48
    Title
    Number of subjects with improvement in the liver necroinflammation score by at least two points
    Time Frame
    Week 48
    Title
    Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point
    Time Frame
    Week 48
    Title
    Number of subjects with adverse events and serious adverse events
    Time Frame
    Baseline up to Week 48

    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: Age between 18 and 65 years Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal Had adequate bone marrow reserve and organ function Are not pregnant and are willing to use contraception, if, of childbearing potential Are willing and able to comply with the protocol and to give written informed consent Other protocol defined inclusion criteria may apply Exclusion Criteria: Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures Any cause for the liver disease other than chronic hepatitis C Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody Previous systemic treatment for Hepatitis C with an interferon or ribavirin Presence of systemic disease that might interfere with subject safety, compliance or evaluation Known allergies to acetaminophen, human serum albumin or mannitol; Glucocorticosteroids or other immunosuppressive drugs taken within 28 days of starting treatment Bearing organ transplants (except cornea) Other protocol defined exclusion criteria may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Theodor Wee, M.D.
    Organizational Affiliation
    Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17654600
    Citation
    Chan HL, Ren H, Chow WC, Wee T; Interferon beta-1a Hepatitis C Study Group. Randomized trial of interferon beta-1a with or without ribavirin in Asian patients with chronic hepatitis C. Hepatology. 2007 Aug;46(2):315-23. doi: 10.1002/hep.21683.
    Results Reference
    result
    Links:
    URL
    http://www.mslifelines.com
    Description
    Full FDA approved prescribing information can be found here

    Learn more about this trial

    A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects

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