The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
JNJ-73763989 will be administered as a SC injection.
Matching placebo to JNJ-73763989 will be administered as a SC injection.
ETV monohydrate film coated tablet will be administered orally.
Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)
Percentage of participants with HDV RNA greater than or equal to (\>=) 2 log10 International Units Per Milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. Target not detected (TND) was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (\<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Time frame: At Week 48
Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With ALT at Week 48 (Multiple Imputation Approach)
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Time frame: At Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tenofovir disoproxil film-coated tablet will be administered orally.
TAF film coated tablet will be administered orally.
Stanford University School of Medicine
Redwood City, California, United States
Harvard Medical School Massachusetts General Hospital
Boston, Massachusetts, United States
Royal Prince Alfred Hospital
Camperdown, Australia
Western Health
Footscray, Australia
Westmead Hospital
Westmead, Australia
Centro Oncológico De Roraima
Boa Vista, Brazil
Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
Manaus, Brazil
Cepem - Centro de Pesquisa Em Medicina Tropical
Porto Velho, Brazil
Beijing Ditan Hospital Capical Medical University
Beijing, China
Peking University People s Hospital
Beijing, China
...and 51 more locations