A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)

Last updated: July 27, 2018
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Terminated

Phase

3

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT01641926
P08450
MK-4031-376
  • Ages > 18
  • All Genders

Study Summary

This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg] positive or negative) who have not previously been treated with interferon.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be able to adhere to dose and visit schedules

  • ≥ 40 kg

  • Hepatitis B surface antigen (HBsAg) positive for at least 6 months

  • Anti-HBs negative

  • Female participants of childbearing potential must agree to use an acceptable method of contraception from at least 2 weeks prior to Day 1 and continue until at least 1month after last dose of study drug Inclusion Criteria for HBeAg(+) participants:

  • HBeAg(+)

  • Anti-HBe(-) Inclusion Criteria for HBeAg(-) participants:

  • HBeAg(-)

  • Anti-HBe(+)

Exclusion

Exclusion Criteria:

  • Co-infection with the human immunodeficiency virus (HIV) or hepatitis C or hepatitis Dvirus

  • Prior treatment with interferon for hepatitis B

  • Use of nucleoside/nucleotide analogues within 6 months of the screening visit or atany time during the study

  • Use of any investigational drug within 30 days of the screening visit

  • Prior treatment with herbal remedies with known hepatotoxicity. All herbal remediesused for hepatitis B treatment must be discontinued before Day 1

  • Evidence of decompensated liver disease including, but not limited to, a history orpresence of clinical ascites, bleeding varices, or hepatic encephalopathy

  • Diabetic and/or hypertensive with clinically significant ocular examination findings

  • History of stroke or transient ischemic attack

  • Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease,ulcerative colitis], celiac disease, rheumatoid arthritis, idiopathic thrombocytopenicpurpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma,sarcoidosis, severe psoriasis requiring oral or injected treatment, or symptomaticthyroid disorder)

  • Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, interstitiallung disease, pulmonary fibrosis, sarcoidosis)

  • Current or history of any clinically significant cardiac abnormalities/dysfunction

  • Any medical condition requiring, or likely to require, chronic systemic administrationof corticosteroids during the course of the trial

  • Myelodysplastic syndromes

  • Organ transplants (including hematopoietic stem cell transplants) other than corneaand hair

  • Pregnant or nursing, or intending to become pregnant during the trial period

Study Design

Total Participants: 402
Study Start date:
November 26, 2012
Estimated Completion Date:
January 21, 2016

Connect with a study center

  • Merck Sharp & Dohme

    North Ryde,
    Australia

    Site Not Available

  • Merck Sharp & Dohme/Australia

    South Granville, NSW 2142
    Australia

    Site Not Available

  • MDS Colombia SAS

    Bogota,
    Colombia

    Site Not Available

  • Merck Sharp & Dohme (Asia) Ltd.

    Hong Kong,
    Hong Kong

    Site Not Available

  • MSD Korea LTD

    Seoul,
    Korea, Republic of

    Site Not Available

  • MSD

    Petaling Jaya,
    Malaysia

    Site Not Available

  • MSD

    Mexico City,
    Mexico

    Site Not Available

  • Merck Sharp & Dohme, Peru S.R.L.

    Lima,
    Peru

    Site Not Available

  • Merck Sharp & Dohme (I.A.) Corporation

    Makati,
    Philippines

    Site Not Available

  • Merck Sharp & Dohme (I.A.) Corp

    Singapore,
    Singapore

    Site Not Available

  • Merck Sharp & Dohme (I.A.) Corp.

    Taipei,
    Taiwan

    Site Not Available

  • MSD (Thailand) Ltd.

    Bangkok,
    Thailand

    Site Not Available

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