Phase
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Merck Sharp & Dohme
North Ryde,
AustraliaSite Not Available
Merck Sharp & Dohme/Australia
South Granville, NSW 2142
AustraliaSite Not Available
MDS Colombia SAS
Bogota,
ColombiaSite Not Available
Merck Sharp & Dohme (Asia) Ltd.
Hong Kong,
Hong KongSite Not Available
MSD Korea LTD
Seoul,
Korea, Republic ofSite Not Available
MSD
Petaling Jaya,
MalaysiaSite Not Available
MSD
Mexico City,
MexicoSite Not Available
Merck Sharp & Dohme, Peru S.R.L.
Lima,
PeruSite Not Available
Merck Sharp & Dohme (I.A.) Corporation
Makati,
PhilippinesSite Not Available
Merck Sharp & Dohme (I.A.) Corp
Singapore,
SingaporeSite Not Available
Merck Sharp & Dohme (I.A.) Corp.
Taipei,
TaiwanSite Not Available
MSD (Thailand) Ltd.
Bangkok,
ThailandSite Not Available
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