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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05123599
Registration number
NCT05123599
Ethics application status
Date submitted
16/11/2021
Date registered
17/11/2021
Titles & IDs
Public title
A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
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Scientific title
A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Virus Infection
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Secondary ID [1]
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2020-005584-30
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Secondary ID [2]
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CR109042
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Universal Trial Number (UTN)
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Trial acronym
OSPREY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-73763989
Treatment: Other - JNJ-64300535
Treatment: Drugs - ETV monohydrate
Treatment: Drugs - Tenofovir disoproxil
Treatment: Drugs - TAF
Experimental: JNJ-73763989 plus JNJ-64300535 plus Nucleos(t)ide Analogs (NAs) - Participants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks (q4w), NA (either Entecavir monohydrate \[ETV\], Tenofovir disoproxil or Tenofovir alafemide \[TAF\]) oral tablets once daily (qd) and JNJ-64300535 intramuscular (IM) injection q4w. From day 187, participants will receive treatment with NA oral tablets qd up to Week 36.
Treatment: Drugs: JNJ-73763989
JNJ-73763989 injection will be administered subcutaneously.
Treatment: Other: JNJ-64300535
JNJ-64300535 deoxyribonucleic acid (DNA) vaccine injection will be administered intramuscularly.
Treatment: Drugs: ETV monohydrate
ETV monohydrate film-coated tablets will be administered orally.
Treatment: Drugs: Tenofovir disoproxil
Tenofovir disoproxil film-coated tablets will be administered orally.
Treatment: Drugs: TAF
TAF film-coated tablets will be administered orally.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with a Reduction of at Least 2 log10 International Units per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline to Week 36
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Assessment method [1]
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Percentage of participants with a reduction of at least 2 log10 IU/mL in HBsAg levels from baseline to Week 36 will be reported.
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Timepoint [1]
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Baseline to Week 36 (end of study intervention)
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Secondary outcome [1]
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Percentage of Participants with at Least 3-fold Increase in Hepatitis B Virus (HBV)- Specific T-Cell Response Against Vaccine Antigen HBV Core and/or Pol
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Assessment method [1]
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Percentage of participants with at least 3-fold increase in HBV-specific T-cell response against vaccine antigen HBV core and/or pol as assessed by enzyme-linked immunospot (ELISpot) will be reported.
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Timepoint [1]
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From Day 103 up to Week 84
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Secondary outcome [2]
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Percentage of Responders Against Vaccine Antigen HBV Core and/or Pol
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Assessment method [2]
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Percentage of responders against vaccine antigen HBV core and/or Pol as assessed by ELISpot will be reported. A responder is defined as a participant with at least a 3-fold increase in HBV-specific T-cell response from the start of vaccination against the vaccine antigen core and/or pol, at least at the last timepoint during the vaccination period.
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Timepoint [2]
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Week 28
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Secondary outcome [3]
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Percentage of Participants with Adverse Events (AEs)
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Assessment method [3]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Timepoint [3]
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Up to Week 84
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Secondary outcome [4]
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Percentage of Participants with Serious AEs
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Assessment method [4]
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A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Timepoint [4]
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Up to Week 84
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Secondary outcome [5]
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Percentage of Participants with Abnormalities in Clinical Laboratory Tests
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Assessment method [5]
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Percentage of participants with abnormalities in clinical laboratory tests (hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, and renal biomarkers) will be reported.
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Timepoint [5]
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Up to Week 84
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Secondary outcome [6]
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Percentage of Participants with Abnormalities in 12- lead Electrocardiograms (ECGs)
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Assessment method [6]
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Percentage of participants with abnormalities in 12- lead ECGs will be reported.
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Timepoint [6]
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Up to Week 84
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Secondary outcome [7]
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Percentage of Participants with Abnormalities in Vital Signs
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Assessment method [7]
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Percentage of participants with abnormalities in vital signs will be reported.
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Timepoint [7]
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Up to Week 84
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Secondary outcome [8]
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Percentage of Participants with Abnormalities in Physical Examinations
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Assessment method [8]
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Percentage of participants with abnormalities in physical examinations will be reported.
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Timepoint [8]
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Up to Week 84
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Secondary outcome [9]
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Percentage of Participants with Solicited Local AEs for JNJ-64300535 up to 7 Days Post Each Vaccination
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Assessment method [9]
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Solicited local AEs include (injection site pain/tenderness, erythema and swelling at the study vaccine injection site and the extent (largest diameter) of any erythema and swelling \[using the ruler supplied\]) will be reported after 7 days of each vaccination.
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Timepoint [9]
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7 days post each vaccination (Up to Day 194)
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Secondary outcome [10]
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Percentage of Participants with Solicited Systematic AEs for JNJ-64300535 up to 7 Days Post Each Vaccination
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Assessment method [10]
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Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) will be reported after 7 days of each vaccination.
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Timepoint [10]
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7 days post each vaccination (Up to Day 194)
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Secondary outcome [11]
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Change from Baseline Over Time in HBsAg Levels
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Assessment method [11]
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Change from baseline over time in HBsAg levels will be reported.
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Timepoint [11]
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Baseline up to Week 84
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Secondary outcome [12]
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Change from Start of Vaccination Over Time in HBsAg Levels
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Assessment method [12]
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Change from start of vaccination over time in HBsAg levels will be reported.
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Timepoint [12]
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From Day 103 up to Week 84
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Secondary outcome [13]
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Percentage of Participants with HBsAg, HBV Deoxyribonucleic Acid (DNA) and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs
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Assessment method [13]
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Percentage of participants with HBsAg, HBV DNA and ALT levels below/above different cut-offs will be reported.
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Timepoint [13]
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Up to Week 84
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Secondary outcome [14]
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Percentage of Participants with HBsAg Seroclearance
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Assessment method [14]
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Percentage of participants with HBsAg seroclearance (HBsAg negativity) will be reported.
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Timepoint [14]
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Up to Week 84
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Secondary outcome [15]
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Percentage of Participants with HBsAg Seroconversion
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Assessment method [15]
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Percentage of participants with HBsAg seroconversion (HBsAg negativity and anti-HBs antibody positivity) will be reported.
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Timepoint [15]
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Up to Week 84
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Secondary outcome [16]
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Time to Achieve HBsAg Seroclearance
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Assessment method [16]
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Time to achieve HBsAg seroclearance will be reported.
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Timepoint [16]
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Up to Week 84
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Secondary outcome [17]
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Time to Achieve HBsAg Seroconversion
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Assessment method [17]
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Time to achieve HBsAg seroconversion will be reported.
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Timepoint [17]
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Up to Week 84
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Secondary outcome [18]
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Percentage of Participants Meeting Nucleos(t)ide Analog (NA) Treatment Completion Criteria
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Assessment method [18]
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Percentage of participants meeting NA treatment completion criteria will be reported.
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Timepoint [18]
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Week 38 and Week 40
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Secondary outcome [19]
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Percentage of Participants with Virological Breakthrough
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Assessment method [19]
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Percentage of participants with virological breakthrough (confirmed on-treatment HBV DNA increase by greater than \[\>\] 1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had HBV DNA level less than \[\<\] lower limit of quantification \[LLOQ\] of the HBV DNA assay) will be reported.
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Timepoint [19]
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Up to Week 36
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Secondary outcome [20]
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Percentage of Participants with HBsAg Seroclearance at Week 60 and Week 84
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Assessment method [20]
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Percentage of participants with HBsAg seroclearance at Weeks 60 and 84 (during follow-up period) will be reported.
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Timepoint [20]
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Weeks 60 and 84
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Secondary outcome [21]
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Percentage of Participants with HBV DNA <LLOQ at Week 60 and Week 84
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Assessment method [21]
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Percentage of participants with HBV DNA \<LLOQ at Weeks 60 and 84 (during follow-up period) will be reported.
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Timepoint [21]
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Weeks 60 and 84
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Secondary outcome [22]
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Percentage of Participants with Viral Flares
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Assessment method [22]
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Percentage of participants with viral flares will be reported.
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Timepoint [22]
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From Week 36 to Week 84
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Secondary outcome [23]
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Percentage of Participants with Biochemical Flares
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Assessment method [23]
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Percentage of participants with biochemical flares will be reported.
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Timepoint [23]
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From Week 36 to Week 84
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Secondary outcome [24]
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Number of TriGrid Delivery System (TDS)-Intramuscular (IM) version 2.0 Device Fault Conditions by Type
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Assessment method [24]
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Number of TDS-IM v2.0 device fault conditions by type will be observed. User reported fault conditions will be documented to enable assessment of the device reliability. Device functions to be assessed include electrode/needle deployment, JNJ-64300535 administration, and electroporation application.
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Timepoint [24]
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From Day 103 to Day 187
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Eligibility
Key inclusion criteria
* Participants must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Participants must have a body mass index (BMI; weight in kilograms [kg] divided by the square of height in meters) between 19.0 and 32.0 kilograms per meter square (kg/m^2), extremes included
* A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day 1 before the first dose of study intervention
* Participants must have chronic hepatitis B virus (HBV) infection. HBV infection must be documented by serum hepatitis B surface antigen (HBsAg) positivity at screening. In addition, chronicity must be documented by any of the following, at least 6 months prior to screening: serum HBsAg positivity, hepatitis B e antigen (HBeAg) positivity or HBV deoxyribonucleic acid (DNA) positivity, alanine aminotransferase (ALT) elevation above upper limit of normal (ULN) without another cause than HBV infection, documented transmission event. If none of the above are available, the following ways of documenting chronicity are acceptable at the time of screening: liver biopsy with changes consistent with chronic HBV, or absence of marker for acute HBV infection such as positive immunoglobulin M (IgM) anti- hepatitis B surface protein (HBs) and anti- hepatitis B core protein (HBc) antibodies. Virologically suppressed participants should: a) be HBeAg-negative and anti- hepatitis B e (HBe) positive, b) be on stable HBV treatment, defined as currently receiving nucleos(t)ide analog (NA) treatment for at least 6 months prior to screening and having been on the same NA treatment regimen (at the same dose) as used in this study for at least 3 months at the time of screening, c) have serum HBV deoxyribonucleic acid (DNA) less than (<) 60 International units per milliliter (IU/mL) on 2 sequential measurements at least 6 months apart (one of which is at screening), and d) have documented ALT values <2.0* ULN on 2 sequential measurements at least 6 months apart (one of which is at screening)
* Participants must have: a) Fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kPa within 6 months prior to screening or at the time of screening, or b) If a Fibroscan result is not available: a liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening
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Minimum age
18
Years
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Maximum age
60
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
* Participants with a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which are considered cured with minimal risk of recurrence)
* Participants with any history of or current clinically significant skin disease requiring regular or periodic treatment
* Participants with clinically relevant alcohol or drug abuse within 12 months of screening
* Participants who had major surgery (example, requiring general anesthesia), excluding diagnostic surgery, within 12 weeks before screening; or will not have fully recovered from surgery; or have surgery planned during the time of expected participation in the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/06/2024
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Edegem
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Country [2]
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France
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State/province [2]
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Clichy
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Country [3]
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France
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State/province [3]
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Lyon
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Country [4]
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Italy
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State/province [4]
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Milano
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Country [5]
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Italy
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State/province [5]
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Pisa
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Country [6]
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New Zealand
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State/province [6]
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Auckland
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Country [7]
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Poland
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State/province [7]
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Myslowice
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Country [8]
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Spain
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State/province [8]
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Barcelona
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Country [9]
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Spain
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State/province [9]
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Santander
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Country [10]
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Taiwan
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State/province [10]
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Kaohsiung City
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Country [11]
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Taiwan
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State/province [11]
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Tao Yuan
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Country [12]
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United Kingdom
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State/province [12]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy of the study intervention based on hepatitis B surface antigen (HBsAg) levels.
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Trial website
https://clinicaltrials.gov/study/NCT05123599
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05123599