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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04585789
Registration number
NCT04585789
Ethics application status
Date submitted
9/10/2020
Date registered
14/10/2020
Titles & IDs
Public title
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
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Scientific title
A Phase 2 Randomized, Open-label, Parallel-group, Multicenter Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Response to Combination Regimens Containing JNJ-73763989 and Nucleos(t)Ide Analog With or Without JNJ-56136379 in Patients With Chronic Hepatitis B Virus Infection
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Secondary ID [1]
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2019-004475-39
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Secondary ID [2]
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CR108790
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Universal Trial Number (UTN)
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Trial acronym
INSIGHT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B
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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: Drugs - JNJ-56136379
Treatment: Drugs - Entecavir (ETV)
Treatment: Drugs - Tenofovir disoproxil
Treatment: Drugs - Tenofovir alafenamide (TAF)
Treatment: Drugs - PegIFN-alpha-2a (Optional)
Experimental: Panel 1: JNJ-73763989+ NA - Ongoing and new participants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks (last injection at Week 44) and nucleos(t)ide analog (NA) treatment (either entecavir \[ETV\], tenofovir disoproxil or tenofovir alafenamide \[TAF\] tablets) once daily up to 48 weeks. Participants may receive optional treatment with pegylated interferon alpha-2a (PegIFN-alpha-2a) after the Week 40 for a duration of either 12 or 24 weeks at the investigator's discretion. As per amendment-5, JNJ-56136379 is no longer included as part of the study intervention and all participants are counted as single arm in each panel.
Experimental: Panel 2: JNJ-73763989+ NA - Ongoing and new participants will receive JNJ-73763989 SC injection once every 4 weeks (last injection at Week 44) and NA treatment (ETV, tenofovir disoproxil or TAF tablets) once daily up to 48 weeks. Participants may receive optional treatment with PegIFN-alpha-2a after the Week 40 for a duration of either 12 or 24 weeks at the investigator's discretion. As per amendment-5, JNJ-56136379 is no longer included as part of the study intervention and all participants are counted as single arm in each panel.
Treatment: Drugs: JNJ-73763989
JNJ-73763989 will be administered subcutaneously once every 4 weeks up to Week 44.
Treatment: Drugs: JNJ-56136379
JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.
Treatment: Drugs: Entecavir (ETV)
ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
Treatment: Drugs: Tenofovir disoproxil
Tenofovir disoproxil will be administered orally once daily up to 48 weeks as NA treatment.
Treatment: Drugs: Tenofovir alafenamide (TAF)
TAF will be administered orally once daily up to 48 weeks as NA treatment.
Treatment: Drugs: PegIFN-alpha-2a (Optional)
PegIFN-alpha-2a injection will be administered subcutaneously once weekly after Week 40 for either 12 or 24 weeks.
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Intervention code [1]
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Treatment: Drugs
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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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Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40
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Assessment method [1]
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The absolute change from baseline to on-treatment liver biopsy timepoint (Week 40) in terms of the percentage of HBsAg-positive hepatocytes (at Week 40) were reported.
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Timepoint [1]
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Baseline, Week 40
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Secondary outcome [1]
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Panel 1 and 2: Change From Baseline in Intrahepatic Immune Response
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Assessment method [1]
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Variation in major cell populations (CD4+ T-cells, CD8+ T-cells, CD45+ T-cells, natural killer cells, and dendritic cells, defined by single cell transcriptomics \[in FNABs\] and immunofluorescence staining \[in core needle biopsies\]) assessed at Week 40 will be reported.
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Timepoint [1]
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Baseline, Week 40
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Secondary outcome [2]
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Panel 1 and 2: Change From Baseline in Intrahepatic Viral Parameters: HBsAg and Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)
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Assessment method [2]
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Change from baseline in intrahepatic viral parameters (HBsAg and HBV DNA, measured in International units \[IU/ml\]) will be reported.
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Timepoint [2]
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Baseline, Week 40
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Secondary outcome [3]
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Panel 1 and 2: Change From Baseline in Intrahepatic Covalently Closed Circular DeoxyriboNucleic Acid (cccDNA) and Pre-genomic RiboNucleic Acid (pgRNA) Levels
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Assessment method [3]
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Change from baseline in intrahepatic cccDNA and pgRNA levels will be reported.
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Timepoint [3]
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Baseline, Week 40
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Secondary outcome [4]
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Panel 1 and 2: Percentage of Participants With HBsAg Seroclearance at Week 72 Without Restarting Nucleos(t)Ide Analog (NA)Treatment
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Assessment method [4]
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Percentage of participants with HBsAg seroclearance (defined as quantitative HBsAg less than lower limit of quantification \[\<LLOQ; HBsAg 0.05 IU/mL\]) at Week 72 without restarting NA treatment will be reported.
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Timepoint [4]
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Week 72 (extended follow-up, ie, 24 weeks after completion of all study interventions at Week 48)
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Secondary outcome [5]
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Panel 1 and 2: Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance
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Assessment method [5]
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Percentage of participants with HBsAg seroclearance (defined as quantitative HBsAg \[\<LLOQ; HBsAg 0.05 IU/mL\]) at Week 72 without restarting NA treatment will be reported.
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Timepoint [5]
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Up to Week 120 (included participants who received optional PegIFN-alpha-2a)
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Secondary outcome [6]
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Panel 1 and 2: Percentage of Participants With HBsAg and Hepatitis B e Antigen (HBeAg) Seroconversion
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Assessment method [6]
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Seroconversion of HBsAg is defined as having achieved HBsAg seroclearance (defined as quantitative HBsAg \<LLOQ \[0.05 IU/mL\]) and appearance of anti-HBs antibodies (defined as a baseline anti-HBs antibodies \[quantitative\] \<LLOQ \[\<10 milli-international units per milliliter (mIU/mL)\] and a post-baseline assessment \>=LLOQ \[\>=10 mIU/mL\]). Seroconversion of HBeAg is defined as having achieved HBeAg seroclearance (defined as \[quantitative\] HBeAg \<LLOQ \[0.11 IU/mL\]) together with appearance of anti-HBe antibodies (defined as a baseline anti-HBe antibodies \[qualitative\] with a "NEGATIVE" result and a post-baseline assessment with "POSITIVE" result).
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Timepoint [6]
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Up to Week 120 (included participants who received optional PegIFN-alpha-2a)
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Secondary outcome [7]
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Panel 1 and 2: Percentage of Participants With Flares
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Assessment method [7]
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Virologic flare (VF;for off-treatment):Derivation 1: HBV DNA \<LLOQ (200 IU/mL) at last observed point on-treatment. VF start:with HBV DNA \>20 IU/mL and VF end:HBV DNA \<=200 IU/mL or NA treatment restart. Derivation 2:HBV DNA \>=LLOQ (20 IU/mL). VF start:HBV DNA log10 increase \>1 log10 from EOT \& VF end:HBV DNA log10 increase from EOT to \<=1 log10 or NA treatment restart. Off-treatment biochemical flare (OTBF) start:ALT and/or AST \>=3x ULN and \>=3\*nadir while participant received no study drugs. Same OTBF end:50% reduction from peak ALT and/or AST and \<3\*ULN. On-treatment BF start:ALT and/or AST \>=3\*ULN \& \>=3\*nadir while participant received no study drugs. Same on-treatment BF end:50% reduction from peak ALT and/or AST and \<3\*ULN. Clinical flare (CF):VF \& BF overlap in time/when BF starts within 4 weeks following VF end. CF start:minimum start of VF \& BF \& CF end:maximum end of VF \& BF (HBV DNA \<=200 IU/mL/\<=1 log10) \& 50% reduction from peak ALT and/or AST \& \<3\*ULN reached during BF.
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Timepoint [7]
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Up to Week 120 (included participants who received optional PegIFN-alpha-2a)
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Secondary outcome [8]
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Panel 1 and 2: Time to Achieve First HBsAg Seroclearance
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Assessment method [8]
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Time to achieve first HBsAg seroclearance (defined as quantitative HBsAg less than lower limit of quantification \[\<LLOQ; HBsAg 0.05 IU/mL\]) will be reported. Time to HBsAg seroclearance is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HBsAg seroclearance (the date ofthe first HBsAg seroclearance - the date of first study intervention intake + 1). The participants who withdrew early from the study before achieving HBsAg seroclearance or who did not achieve HBsAg seroclearance will be censored at the last available HBsAg assessment.
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Timepoint [8]
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Up to Week 120 (included participants who received optional PegIFN-alpha-2a)
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Secondary outcome [9]
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Panel 1 and 2: Percentage of Participants With Virologic Breakthrough
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Assessment method [9]
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Virological breakthrough was defined as confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level \< LLOQ (20 IU/mL) or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level \<LLOQ of the HBV DNA assay. Confirmed HBV DNA increase/level means that the criterion should be fulfilled at 2 or more consecutive time points or at the last observed on-treatment time point. On treatment is defined as the time period in which the participant receives any of the study interventions (JNJ-3989 and/or JNJ 6379 and/or NA and/or PegIFN-a2a). Percentage of participants with virologic breakthrough on treatment will be reported.
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Timepoint [9]
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Up to Week 48
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Secondary outcome [10]
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Panel 1 and 2: Change From Baseline in HBV-Specific Peripheral Blood T-cell Responses During the Study Intervention and Follow-up Phases
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Assessment method [10]
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Change from baseline in HBV-specific peripheral blood T-cell responses during the study intervention and follow-up phases will be reported. HBV-specific T-cells were characterized in peripheral blood mononuclear cell immune analyss by binding assays (multimer staining) combined with downstream TCR and transcriptome profiling.
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Timepoint [10]
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Baseline up to Week 48
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Secondary outcome [11]
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Panel 1 and 2: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [11]
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An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. 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 [11]
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From Day 1 (Week 0) up to Week 120 (included participants who received optional PegIFN-alpha-2a)
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Secondary outcome [12]
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Panel 1 and 2: Percentage of Participants With Abnormalities in Selected Clinical Laboratory Tests, Electrocardiogram (ECG), Vital Signs And Physical Examination
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Assessment method [12]
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Percentage of participants with abnormalities in clinical laboratory tests, ECG, vital signs and physical examination will be reported.
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Timepoint [12]
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From Day 1 (Week 0) up to Week 120 (included participants who received optional PegIFN-alpha-2a)
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Secondary outcome [13]
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Panel 1 and 2: Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Optionally of JNJ-56136379, NA and/or Pegylated Interferon Alpha-2a (PegIFN-alpha-2a)
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Assessment method [13]
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Plasma samples will be analyzed to determine concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and optionally of JNJ-56136379, NA and/or PegIFN-alpha-2a.
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Timepoint [13]
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Panel 1 and 2: post-dose on Days 1, 29, 85, 169, 337
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Eligibility
Key inclusion criteria
* Medically stable on the basis of physical examination, medical history, vital signs, and triplicate 12-lead electrocardiogram (ECG) performed at screening
* Hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening: participants be either currently not treated with HBeAg positive status or virologically (nucleos[t]ide analog [NA]) suppressed with HBeAg negative status
* Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening
* Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
* Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
* Fibroscan liver stiffness measurement less than and equal to (<=) 9 Kilopascal (kPa) within 6 months prior to screening or at the time of screening
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Minimum age
18
Years
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Maximum age
65
Years
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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
* Evidence of infection with hepatitis A, C, D or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
* History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
* History or signs of cirrhosis or portal hypertension, signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities on an abdominal ultrasound performed within 6 months prior to screening or at the time of screening
* Presence of coagulopathy or bleeding disorder as indicated by: (a) International normalized ratio (INR) greater than or equal to (>=) 1.1* upper limit of normal (ULN); (b) Partial thromboplastin time >1.1*ULN; (c) Any signs of prolonged bleeding (>10 minutes)
* Presence of hemoglobinopathy (including sickle cell disease, thalassemia)
* Liver biopsy performed prior to screening that led to complications and that in the opinion of the investigator would prohibit another liver biopsy
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Study design
Purpose of the study
Other
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Allocation to intervention
Non-randomised trial
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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
Parallel
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Other design features
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Phase
Phase 2
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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
11/03/2021
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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
9/01/2024
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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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United States of America
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State/province [1]
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Maryland
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Belgium
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State/province [2]
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Edegem
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Canada
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State/province [3]
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Ontario
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Country [4]
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France
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State/province [4]
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Clichy
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Country [5]
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Germany
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State/province [5]
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Hamburg
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Country [6]
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Italy
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State/province [6]
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Milano
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Country [7]
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New Zealand
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State/province [7]
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Auckland
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Country [8]
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Poland
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State/province [8]
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Myslowice
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Country [9]
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United Kingdom
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State/province [9]
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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 assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.
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Trial website
https://clinicaltrials.gov/study/NCT04585789
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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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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 \& 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
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/89/NCT04585789/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/89/NCT04585789/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04585789