Hepatitis B, ChronicPhase 2NCT04129554
A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
A Phase 2 study testing JNJ-73763989, JNJ-56136379 and Entecavir (ETV) monohydrate in people with Hepatitis B, Chronic, run by Janssen Sciences Ireland UC at 41 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- JNJ-73763989, JNJ-56136379 and Entecavir (ETV) monohydrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 41 sitesin 7 countries
- Study dates
- 6 Nov 2019to 9 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
- Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening
- Hepatitis B e (antigen) (HBeAg)-negative on stable nucleotide analogue (NA) treatment for at least 24 months prior to screening
- 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 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
- Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (<) 9 Kilopascal (kPa) at screening
Who cannot join
- 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 or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
- Evidence of liver disease of non-HBV etiology
- History or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size ≥12 cm) or signs of hepatocellular carcinoma (HCC)
- Significant laboratory abnormalities as defined in the protocol at screening
- Participants with a history of malignancy within 5 years before screening
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- Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
- History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
- Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
- History of or current clinically significant skin disease or drug rash
- Known allergies, hypersensitivity, or intolerance to JNJ-73763989 and JNJ-56136379 or their excipients or to placebo content
- Contraindications to the use of entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF) per local prescribing information
- Participants who have taken any therapies disallowed per protocol
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
Germany8 sites
Universitatsklinikum Essen
Essen, 45147
Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
Frankfurt, 60590
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106
ICH Study Center GmbH & Co. KG
Hamburg, 20146
University Medical Center
Hamburg, D-20246
Medizinische Hochschule Hannover
Hanover, 30625
Universitaetsklinikum Leipzig
Leipzig, 04103
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, 55131
France7 sites
Hopital Beaujon
Clichy, 92110
Hopital de La Croix Rousse
Lyon, 69004
Hopital Saint Joseph
Marseille, 13008
Hopital Cochin
Paris, 75014
Chu Rennes Hopital Pontchaillou
Rennes, 35033
CHU Nancy Brabois
Vandœuvre-lès-Nancy, 54511
Hopital Paul Brousse
Villejuif, 94800
Spain6 sites
Hosp Clinic de Barcelona
Barcelona, 8028
Hosp Univ Vall D Hebron
Barcelona, 8035
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp. Univ. Pta. de Hierro Majadahonda
Madrid, 28222
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Hosp. Gral. Univ. Valencia
Valencia, 46014
United Kingdom6 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
North Manchester General Hospital
Crumpsall, M8 5RB
Glasgow Royal Infirmary
Glasgow, G31 2ER
Grahame Hayton Unit
London, E1 1BB
Kings College Hospital
London, SE5 9RF
St Georges University of London and St George's University Hospitals NHS Foundation Trust
London, SW17 0RE
Belgium5 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
SGS Belgium NV
Edegem, 2650
UZ Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
Italy5 sites
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, 98124
Irccs Ospedale Maggiore Di Milano
Milan, 20122
Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara
Modena, 41126
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
Rome, 00161
Poland4 sites
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
Bydgoszcz, 85-030
Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
Gdansk, 80-462
ID Clinic
Mysłowice, 41-400
SP ZOZ Wroclawskie Centrum Zdrowia
Wroclaw, 50-136
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).
Read the detailed description
Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute or chronic infection. It consists of a so-called nucleocapsid in which viral DNA is packed with hepatitis B core protein (HBc) and membranous envelope containing hepatitis B surface antigen (HBsAg). Chronic HBV infection may lead to serious illnesses like cirrhosis and hepatocellular carcinoma (HCC). Oral treatment with NAs is effective at suppressing viral DNA formation and lowering virus concentration in blood to levels below lower limit of quantification (LLOQ). JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism but rarely lead to functional cure defined as sustained loss of HBs Ag and HBV DNA in serum. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for treatment of chronic HBV infection. The aim of study is to evaluate efficacy of 48-week study intervention with JNJ-3989+JNJ-6379+NA regimen compared to NA alone, assessed by HBsAg seroclearance at Week 72 (i.e., 24 weeks after completion of all study interventions at Week 48) without restarting NA treatment in HBeAg negative virologically suppressed chronic hepatitis B (CHB) infected participants who received NA treatment for at least 2 years prior to screening. The study will be 2.3 years and will be conducted in 3 phases: a screening phase (4 weeks), a study intervention phase (48 weeks), and a follow-up phase (48 weeks). Safety will be evaluated by AEs including AEs of special interest to any of the study interventions, clinical laboratory tests, ECGs, vital signs, and physical examinations.
- Conditions
- Hepatitis B, Chronic
- Being tested
- JNJ-73763989, JNJ-56136379, Placebo for JNJ-73763989, Placebo for JNJ-56136379, Entecavir (ETV) monohydrate
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-73763989Drug
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks.
JNJ-56136379Drug
JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.
Placebo for JNJ-73763989Drug
Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.
Placebo for JNJ-56136379Drug
Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.
Entecavir (ETV) monohydrateDrug
ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
Tenofovir disoproxil fumarate (TDF)Drug
TDF will be administered orally once daily up to 48 weeks as NA treatment.
Tenofovir alafenamide (TAF)Drug
TAF will be administered orally once daily up to 48 weeks as NA treatment.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-73763989+ JNJ-56136379+ NA | Experimental | Participants will receive fixed dose of JNJ-73763989 subcutaneous injection once every 4 weeks along with fixed dose of JNJ-56136379 tablet once daily and nucleos(t)ide analog (NA) treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide [TAF]) once daily up to 48 weeks. Receives: Drug: JNJ-73763989; Drug: JNJ-56136379; Drug: Entecavir (ETV) monohydrate; Drug: Tenofovir disoproxil fumarate (TDF); Drug: Tenofovir alafenamide (TAF) |
| Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA | Placebo comparator | Participants will receive matching placebo for JNJ-73763989 subcutaneous injection once every 4 weeks with matching placebo for JNJ-56136379 once daily and NA treatment (either ETV, TDF or TAF) once daily up to 48 weeks. Receives: Drug: Placebo for JNJ-73763989; Drug: Placebo for JNJ-56136379; Drug: Entecavir (ETV) monohydrate; Drug: Tenofovir disoproxil fumarate (TDF); Drug: Tenofovir alafenamide (TAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment
Percentage of participants with HBsAg seroclearance at Week 72 (24 weeks after completion of all study interventions at Week 48) without restarting NA treatment was reported. Seroclearance at Week 72 of the treatment defined as a confirmed loss of HBsAg at Week 72. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.
Measured: Week 72
Secondary outcomes (36)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then).
Measured: From screening up to Week 102
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a clinical study participant who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then). SAEs included any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the off spring of a study participant.
Measured: From screening up to 102 weeks
Percentage of Participants With HBsAg Seroclearance at Week 48
Percentage of participants with hepatitis B surface antigen (HBsAg) seroclearance at Week 48 was reported. Seroclearance at Week 48 of the treatment defined as a confirmed loss of HBsAg at Week 48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.
Measured: Week 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48
Percentage of participants with HBV DNA <LLOQ (20 international units per milliliters [IU/mL]) at Week 48 was reported.
Measured: Week 48
Percentage of Participants With HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment)
Percentage of participants with HBsAg seroclearance at Week 96 (48 weeks after stopping all study interventions at Week 48 without restarting NA treatment) was reported. Seroclearance at Week 96 of the treatment defined as a confirmed loss of HBsAg at Week 96. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. Missing values were imputed by last observation carried forward (LOCF).
Measured: Week 96
Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance
Percentage of participants with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen [HBsAg] and HBV DNA) (HBsAg >= lower limit of quantification [LLOQ] and HBV DNA<2000 IU/mL; HBsAg >= LLOQ and LLOQ <= HBV DNA < 2000 IU/mL) off-treatment was reported.
Measured: Baseline (Day 1) up to Week 96
Percentage of Participants With HBsAg Seroconversion at Week 96
Percentage of participants with HBsAg seroconversion were reported. HBsAg seroconversion was defined as HBsAg seroclearance together with appearance of anti-hepatitis B surface (HBs) or anti-hepatitis e (HBe) antibodies, respectively.
Measured: Week 96
Change From Baseline in HBsAg Values at Weeks 48, 72, and 96
Change from baseline in HBsAg values was reported.
Measured: Baseline (Day 1), Weeks 48, 72, and 96
Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96
Change from baseline in HBV DNA values was reported. Participants were considered as virologically suppressed if they were on stable HBV treatment (receiving NA treatment [ETV, TDF, or TAF)] for at least 24 months prior to screening and were on the same dose of NA treatment regimen for at least 3 months at the time of screening, and had serum HBV DNA less than (<)60 IU/mL on 2 sequential measurements at least 6 months and had documented alanine aminotransferase values <2.0* upper limit of normal on 2 sequential measurements at least 6 months apart.
Measured: Baseline (Day 1), Weeks 48, 72, and 96
Time to Achieve First HBsAg Seroclearance
Time to achieve first HBsAg seroclearance was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg seroclearance.
Measured: Baseline (Day 1) up to Week 96
Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline
Percentage of participants with reduction of >1 log10 in HBsAg Levels IU/mL from baseline was reported.
Measured: Baseline (Day 1) up to Week 96
Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96
Percentage of participants with HBsAg Levels <100 IU/mL at Weeks 48, 72, and 96 was reported.
Measured: Weeks 48, 72, and 96
Percentage of Participants With HBV DNA Levels Less Than (<) LLOQ From Baseline up to Week 96 (End of Study)
Percentage of Participants with HBV DNA levels <LLOQ (20 IU/mL) was reported.
Measured: Baseline (Day 1) up to Week 96
Percentage of Participants With Flares
Percentage of participants with flares (virologic, biochemical and clinical flares) was reported. Biochemical flare was defined as confirmed alanine transaminase flare and/or aspartate aminotransferase flare >=3*upper limit of normal and >=3*nadir. The start of a confirmed virologic flare was defined as the first date of two consecutive visits with HBV DNA >200 IU/mL. The end date of the same confirmed virologic flare was defined as the first date when HBV DNA value returns to less than or equal to (<=)200 IU/mL or the date of NA treatment restart, whichever comes first. Clinical flare was defined as participants with both virologic and biochemical flare.
Measured: Baseline (Day 1) up to Week 96
Percentage of Participants With Virologic Breakthrough
Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by more than (>) 1 log10 IU/mL from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below <LLOQ of the HBV DNA assay was reported.
Measured: Baseline (Day 1) up to Week 48
Percentage of Participants Requiring NA Re-Treatment During Follow-up
Percentage of participants requiring NA re-treatment (either ETV, TDF, or TAF) during follow-up was reported.
Measured: Baseline (Day 1) up to Week 96
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics
Correlation coefficient between on-treatment HBsAg change from baseline with on-treatment HBV blood markers and baseline characteristics was reported at different timepoints (against age, baseline NA treatment duration, HBsAg value at baseline, HBsAg values at Weeks 24 and 48).
Measured: Baseline (Day 1) to Week 96
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989)
C(predose) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989)
Cmax was defined as the maximum observed concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763976 (Molecule of JNJ-73763989)
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763976 (Molecule of JNJ-73763989)
C(24h) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: 24 hours postdose at Weeks 4, 8, 12, and 16
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-73763976 (Molecule of JNJ-73763989)
AUC(0-24h) was defined as the area under the concentration of JNJ-73763976 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])
Cmax(Dose Normalized) was defined as the maximum observed concentration of JNJ-73763976 (a molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)
AUC([0-24h], Dose Normalized) was defined as the area under the concentration of JNJ-73763976 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: 0 to 24 hours post-dose at Weeks 4, 8, 12, and 16
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989)
C(predose) was defined as the observed plasma concentration of JNJ-73763924 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989)
Cmax was defined as the maximum concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763924 (Molecule of JNJ-73763989)
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763924 (Molecule of JNJ-73763989)
C(24h) was defined as the observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: 24 hours postdose at Weeks 4, 8, 12, and 16
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24h]) of JNJ-73763924 (Molecule of JNJ-73763989)
AUC(0-24h) was defined as the area under the concentration of JNJ-73763924 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hour of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])
Cmax(Dose Normalized) was defined as the maximum observed analyte concentration of JNJ-73763924 (molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)
AUC([0-24h], Dose Normalized) was defined as the area under the analyte concentration JNJ-73763924 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379
C(predose) was defined as the observed plasma concentration at predose of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379
Cmax was defined as the maximum observed concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379
Ctau was defined as the observed or predicted concentration at the end of a dosing interval of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379
AUCtau was defined as the area under the analyte concentration versus time curve during a dosing interval at steady state of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Measured: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start6 Nov 2019
- Primary completion8 Jul 2021
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Sciences Ireland UC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Sciences Ireland UC Clinical Trial, Study director, Janssen Sciences Ireland UC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129554
- Sponsor's protocol ID
- CR108679
- Other IDs
- 73763989PAHPB2002, 2019-002674-31, 2019
- Status last verified
- Jan 2025
- First submitted
- 15 Oct 2019
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
van Bommel F, Verbinnen T, Agarwal K, Vanwolleghem T, Lampertico P, Buti M, Janczewska E, Bourliere M, Jezorwski J, Donohue K, Kim G, Kakuda TN, De Meyer S, Bakala A, Biermer M, Lenz O. Serum levels of hepatitis B core antibodies and hepatitis B core-related antigen at the time of nucleos(t)ide analog cessation and risk of severe flares in patients with chronic hepatitis B. Hepatol Commun. 2025 Feb 26;9(3):e0656. doi: 10.1097/HC9.0000000000000656. eCollection 2025 Mar 1.
PubMed 40008890Agarwal K, Buti M, van Bommel F, Lampertico P, Janczewska E, Bourliere M, Vanwolleghem T, Lenz O, Verbinnen T, Kakuda TN, Mayer C, Jezorwski J, Muenz D, Beumont M, Kalmeijer R, Biermer M, Lonjon-Domanec I. JNJ-73763989 and bersacapavir treatment in nucleos(t)ide analogue-suppressed patients with chronic hepatitis B: REEF-2. J Hepatol. 2024 Sep;81(3):404-414. doi: 10.1016/j.jhep.2024.03.046. Epub 2024 Apr 5.
PubMed 38583491
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT04129554
- Acronym / sponsor ID
- CR108679
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Janssen Sciences Ireland UCIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).
Detailed description
Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute or chronic infection. It consists of a so-called nucleocapsid in which viral DNA is packed with hepatitis B core protein (HBc) and membranous envelope containing hepatitis B surface antigen (HBsAg). Chronic HBV infection may lead to serious illnesses like cirrhosis and hepatocellular carcinoma (HCC). Oral treatment with NAs is effective at suppressing viral DNA formation and lowering virus concentration in blood to levels below lower limit of quantification (LLOQ). JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism but rarely lead to functional cure defined as sustained loss of HBs Ag and HBV DNA in serum. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for treatment of chronic HBV infection. The aim of study is to evaluate efficacy of 48-week study intervention with JNJ-3989+JNJ-6379+NA regimen compared to NA alone, assessed by HBsAg seroclearance at Week 72 (i.e., 24 weeks after completion of all study interventions at Week 48) without restarting NA treatment in HBeAg negative virologically suppressed chronic hepatitis B (CHB) infected participants who received NA treatment for at least 2 years prior to screening. The study will be 2.3 years and will be conducted in 3 phases: a screening phase (4 weeks), a study intervention phase (48 weeks), and a follow-up phase (48 weeks). Safety will be evaluated by AEs including AEs of special interest to any of the study interventions, clinical laboratory tests, ECGs, vital signs, and physical examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-73763989+ JNJ-56136379+ NA | Experimental | Drug: JNJ-73763989, Drug: JNJ-56136379, Drug: Entecavir (ETV) monohydrate, Drug: Tenofovir disoproxil fumarate (TDF), Drug: Tenofovir alafenamide (TAF)Participants will receive fixed dose of JNJ-73763989 subcutaneous injection once every 4 weeks along with fixed dose of JNJ-56136379 tablet once daily and nucleos(t)ide analog (NA) treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide [TAF]) once daily up to 48 weeks. |
| Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA | Placebo comparator | Drug: Placebo for JNJ-73763989, Drug: Placebo for JNJ-56136379, Drug: Entecavir (ETV) monohydrate, Drug: Tenofovir disoproxil fumarate (TDF), Drug: Tenofovir alafenamide (TAF)Participants will receive matching placebo for JNJ-73763989 subcutaneous injection once every 4 weeks with matching placebo for JNJ-56136379 once daily and NA treatment (either ETV, TDF or TAF) once daily up to 48 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
- Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening
- Hepatitis B e (antigen) (HBeAg)-negative on stable nucleotide analogue (NA) treatment for at least 24 months prior to screening
- 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 kilogram per meter square (kg/m^2), extremes included
Key exclusion criteria (13 listed)
- 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 or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
- Evidence of liver disease of non-HBV etiology
- History or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size ≥12 cm) or signs of hepatocellular carcinoma (HCC)
- Significant laboratory abnormalities as defined in the protocol at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-73763989JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks. | Drug | JNJ-73763989+ JNJ-56136379+ NA |
| JNJ-56136379JNJ-56136379 tablets will be administered orally once daily up to 48 weeks. | Drug | JNJ-73763989+ JNJ-56136379+ NA |
| Placebo for JNJ-73763989Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks. | Drug | Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA |
| Placebo for JNJ-56136379Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks. | Drug | Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA |
| Entecavir (ETV) monohydrateETV tablet will be administered orally once daily up to 48 weeks as NA treatment. | Drug | JNJ-73763989+ JNJ-56136379+ NA, Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA |
| Tenofovir disoproxil fumarate (TDF)TDF will be administered orally once daily up to 48 weeks as NA treatment. | Drug | JNJ-73763989+ JNJ-56136379+ NA, Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA |
| Tenofovir alafenamide (TAF)TAF will be administered orally once daily up to 48 weeks as NA treatment. | Drug | JNJ-73763989+ JNJ-56136379+ NA, Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA |
Primary outcome
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment
Time frame: Week 72
Percentage of participants with HBsAg seroclearance at Week 72 (24 weeks after completion of all study interventions at Week 48) without restarting NA treatment was reported. Seroclearance at Week 72 of the treatment defined as a confirmed loss of HBsAg at Week 72. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.
36 secondary outcomes
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From screening up to Week 102
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Time frame: From screening up to 102 weeks
Percentage of Participants With HBsAg Seroclearance at Week 48
Time frame: Week 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48
Time frame: Week 48
Percentage of Participants With HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment)
Time frame: Week 96
Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With HBsAg Seroconversion at Week 96
Time frame: Week 96
Change From Baseline in HBsAg Values at Weeks 48, 72, and 96
Time frame: Baseline (Day 1), Weeks 48, 72, and 96
Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96
Time frame: Baseline (Day 1), Weeks 48, 72, and 96
Time to Achieve First HBsAg Seroclearance
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96
Time frame: Weeks 48, 72, and 96
Percentage of Participants With HBV DNA Levels Less Than (<) LLOQ From Baseline up to Week 96 (End of Study)
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With Flares
Time frame: Baseline (Day 1) up to Week 96
Percentage of Participants With Virologic Breakthrough
Time frame: Baseline (Day 1) up to Week 48
Percentage of Participants Requiring NA Re-Treatment During Follow-up
Time frame: Baseline (Day 1) up to Week 96
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics
Time frame: Baseline (Day 1) to Week 96
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989)
Time frame: Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989)
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763976 (Molecule of JNJ-73763989)
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763976 (Molecule of JNJ-73763989)
Time frame: 24 hours postdose at Weeks 4, 8, 12, and 16
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-73763976 (Molecule of JNJ-73763989)
Time frame: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)
Time frame: 0 to 24 hours post-dose at Weeks 4, 8, 12, and 16
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989)
Time frame: Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989)
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763924 (Molecule of JNJ-73763989)
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763924 (Molecule of JNJ-73763989)
Time frame: 24 hours postdose at Weeks 4, 8, 12, and 16
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24h]) of JNJ-73763924 (Molecule of JNJ-73763989)
Time frame: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)
Time frame: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379
Time frame: Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379
Time frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40008890van Bommel F, Verbinnen T, Agarwal K, Vanwolleghem T, Lampertico P, Buti M, Janczewska E, Bourliere M, Jezorwski J, Donohue K, Kim G, Kakuda TN, De Meyer S, Bakala A, Biermer M, Lenz O. Serum levels of hepatitis B core antibodies and hepatitis B core-related antigen at the time of nucleos(t)ide analog cessation and risk of severe flares in patients with chronic hepatitis B. Hepatol Commun. 2025 Feb 26;9(3):e0656. doi: 10.1097/HC9.0000000000000656. eCollection 2025 Mar 1.
- Derived from this study: PubMed 38583491Agarwal K, Buti M, van Bommel F, Lampertico P, Janczewska E, Bourliere M, Vanwolleghem T, Lenz O, Verbinnen T, Kakuda TN, Mayer C, Jezorwski J, Muenz D, Beumont M, Kalmeijer R, Biermer M, Lonjon-Domanec I. JNJ-73763989 and bersacapavir treatment in nucleos(t)ide analogue-suppressed patients with chronic hepatitis B: REEF-2. J Hepatol. 2024 Sep;81(3):404-414. doi: 10.1016/j.jhep.2024.03.046. Epub 2024 Apr 5.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Sciences Ireland UC Clinical Trial study director
Janssen Sciences Ireland UC
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-73763989, JNJ-56136379 and Entecavir (ETV) monohydrate in people with Hepatitis B, Chronic, run by Janssen Sciences Ireland UC at 41 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Germany, France, Spain, United Kingdom, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment (time frame: Week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129554, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.