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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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-73763989
JNJ-56136379
Placebo for JNJ-73763989
Placebo for JNJ-56136379
Entecavir (ETV) monohydrate
Tenofovir disoproxil fumarate (TDF)
Tenofovir alafenamide (TAF)
Sponsored by
Janssen Sciences Ireland UC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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 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
  • 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

Sites / Locations

  • Cliniques Universitaires Saint-Luc
  • SGS Belgium NV
  • UZ Antwerpen
  • Universitair Ziekenhuis Gent
  • UZ Leuven
  • Hopital Beaujon
  • Hopital de La Croix Rousse
  • Hopital Saint Joseph
  • Hopital Cochin
  • Chu Rennes - Hopital Pontchaillou
  • CHU Nancy Brabois
  • Hopital Paul Brousse
  • Universitatsklinikum Essen
  • Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
  • Universitatsklinikum Freiburg
  • ICH Study Center GmbH & Co. KG
  • University Medical Center
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Leipzig
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Irccs Ospedale Maggiore Di Milano
  • Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara
  • Azienda Ospedaliero Universitaria Pisana
  • Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
  • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
  • Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
  • ID Clinic
  • SP ZOZ Wroclawskie Centrum Zdrowia
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. Vall D Hebron
  • Hosp. Univ. 12 de Octubre
  • Hosp. Univ. Pta. de Hierro Majadahonda
  • Hosp. Univ. Marques de Valdecilla
  • Hosp. Gral. Univ. Valencia
  • Queen Elizabeth Hospital
  • North Manchester General Hospital
  • Glasgow Royal Infirmary
  • Grahame Hayton Unit
  • Kings College Hospital
  • St George's, University of London and St George's University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JNJ-73763989+ JNJ-56136379+ NA

Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 (24 weeks after completion of all study interventions at Week 48) 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 nucleos(t)ide analog (NA) treatment will be reported.

Secondary Outcome Measures

Number of Participants with Adverse Events (AEs) and Serious AEs
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.
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinically significant laboratory findings (urine chemistry and renal biomarkers) will be reported.
Percentage of Participants with HBsAg Seroclearance at Week 48
Percentage of participants with HBsAg seroclearance at week 48 will be reported.
Percentage of Participants with HBV DNA less than (<) Lower Limit of Quantification (LLOQ) at Week 48
Percentage of participants with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) <LLOQ at week 48 will be reported.
Percentage of Participants with HBsAg Seroclearance at Week 96 (48 Weeks After Completion of all Study Intervention) Without Restarting NA Treatment
Percentage of participants with HBsAg seroclearance up to week 96 (48 weeks after completion of all study intervention) without restarting NA treatment will be reported.
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], hepatitis B e antigen [HBeAg], HBV DNA and alanine aminotransferase [ALT]) will be reported.
Time to Achieve First HBsAg Seroclearance
Time to achieve first HBsAg seroclearance will be reported.
Percentage of participants with HBV DNA levels with <LLOQ
Percentage of participants with HBV DNA levels with lower limit of quantification (<LLOQ) assay will be reported.
Percentage of Participants with Virologic Breakthrough
Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by greater 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 will be reported.
Percentage of Participants with Flares
Percentage of participants with flares (virologic, biochemical and clinical flares) will be reported.
Percentage of Participants Requiring NA Re-Treatment During Follow-up
Percentage of participants requiring NA re-treatment during follow-up will be reported.
Association Between Baseline Characteristics and On-Treatment Viral Blood Markers with Selected Off-Treatment Responses
Identification of baseline characteristics and on treatment viral blood markers (e.g., HBV DNA, HBsAg, ALT) associated with sustained off-treatment responses will be reported.
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-73763989
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-56136379
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of NA
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.

Full Information

First Posted
October 15, 2019
Last Updated
June 30, 2023
Sponsor
Janssen Sciences Ireland UC
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1. Study Identification

Unique Protocol Identification Number
NCT04129554
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
June 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Sciences Ireland UC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JNJ-73763989+ JNJ-56136379+ NA
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JNJ-73763989
Intervention Description
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
JNJ-56136379
Intervention Description
JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo for JNJ-73763989
Intervention Description
Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo for JNJ-56136379
Intervention Description
Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Entecavir (ETV) monohydrate
Intervention Description
ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate (TDF)
Intervention Description
TDF will be administered orally once daily up to 48 weeks as NA treatment.
Intervention Type
Drug
Intervention Name(s)
Tenofovir alafenamide (TAF)
Intervention Description
TAF will be administered orally once daily up to 48 weeks as NA treatment.
Primary Outcome Measure Information:
Title
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 (24 weeks after completion of all study interventions at Week 48) Without Restarting NA Treatment
Description
Percentage of participants with HBsAg seroclearance at week 72 (24 weeks after completion of all study interventions at Week 48) without restarting nucleos(t)ide analog (NA) treatment will be reported.
Time Frame
Week 72
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs) and Serious AEs
Description
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.
Time Frame
Up to 102 weeks
Title
Number of Participants with Abnormalities in Clinical Laboratory Tests
Description
Number of participants with abnormalities in clinically significant laboratory findings (urine chemistry and renal biomarkers) will be reported.
Time Frame
Up to 102 weeks
Title
Percentage of Participants with HBsAg Seroclearance at Week 48
Description
Percentage of participants with HBsAg seroclearance at week 48 will be reported.
Time Frame
Week 48
Title
Percentage of Participants with HBV DNA less than (<) Lower Limit of Quantification (LLOQ) at Week 48
Description
Percentage of participants with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) <LLOQ at week 48 will be reported.
Time Frame
Week 48
Title
Percentage of Participants with HBsAg Seroclearance at Week 96 (48 Weeks After Completion of all Study Intervention) Without Restarting NA Treatment
Description
Percentage of participants with HBsAg seroclearance up to week 96 (48 weeks after completion of all study intervention) without restarting NA treatment will be reported.
Time Frame
Up to Week 96
Title
Percentage of Participants with (Sustained) Reduction, Suppression, and/or Seroclearance
Description
Percentage of participants with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen [HBsAg], hepatitis B e antigen [HBeAg], HBV DNA and alanine aminotransferase [ALT]) will be reported.
Time Frame
Up to Week 96
Title
Time to Achieve First HBsAg Seroclearance
Description
Time to achieve first HBsAg seroclearance will be reported.
Time Frame
Up to Week 96
Title
Percentage of participants with HBV DNA levels with <LLOQ
Description
Percentage of participants with HBV DNA levels with lower limit of quantification (<LLOQ) assay will be reported.
Time Frame
Up to Week 96
Title
Percentage of Participants with Virologic Breakthrough
Description
Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by greater 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 will be reported.
Time Frame
Up to Week 48
Title
Percentage of Participants with Flares
Description
Percentage of participants with flares (virologic, biochemical and clinical flares) will be reported.
Time Frame
Up to week 96
Title
Percentage of Participants Requiring NA Re-Treatment During Follow-up
Description
Percentage of participants requiring NA re-treatment during follow-up will be reported.
Time Frame
Up to week 96
Title
Association Between Baseline Characteristics and On-Treatment Viral Blood Markers with Selected Off-Treatment Responses
Description
Identification of baseline characteristics and on treatment viral blood markers (e.g., HBV DNA, HBsAg, ALT) associated with sustained off-treatment responses will be reported.
Time Frame
Baseline to week 72
Title
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-73763989
Description
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Time Frame
Days 1, 29, 85, 169 and 337
Title
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-56136379
Description
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Time Frame
Days 1, 29, 85, 169 and 337
Title
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of NA
Description
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Time Frame
Days 1, 29, 85, 169 and 337

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Sciences Ireland UC Clinical Trial
Organizational Affiliation
Janssen Sciences Ireland UC
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
SGS Belgium NV
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Chu Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Nancy Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
ICH Study Center GmbH & Co. KG
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
University Medical Center
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55121
Country
Germany
Facility Name
Azienda Ospedaliera Universitaria Policlinico G. Martino
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
Irccs Ospedale Maggiore Di Milano
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara
City
Modena
ZIP/Postal Code
41126
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
ID Clinic
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
SP ZOZ Wroclawskie Centrum Zdrowia
City
Wroclaw
ZIP/Postal Code
50-136
Country
Poland
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. Pta. de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Gral. Univ. Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Crumpsall
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Facility Name
Grahame Hayton Unit
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RF
Country
United Kingdom
Facility Name
St George's, University of London and St George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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