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

PHASE2CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

November 6, 2019

Primary Completion Date

July 8, 2021

Study Completion Date

June 9, 2022

Conditions
Hepatitis B, Chronic
Interventions
DRUG

JNJ-73763989

JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks.

DRUG

JNJ-56136379

JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.

DRUG

Placebo for JNJ-73763989

Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.

DRUG

Placebo for JNJ-56136379

Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.

DRUG

Entecavir (ETV) monohydrate

ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.

DRUG

Tenofovir disoproxil fumarate (TDF)

TDF will be administered orally once daily up to 48 weeks as NA treatment.

DRUG

Tenofovir alafenamide (TAF)

TAF will be administered orally once daily up to 48 weeks as NA treatment.

Trial Locations (41)

1200

Cliniques Universitaires Saint Luc, Brussels

2650

SGS Belgium NV, Edegem

UZ Antwerpen, Edegem

3000

UZ Leuven, Leuven

8028

Hosp Clinic de Barcelona, Barcelona

8035

Hosp Univ Vall D Hebron, Barcelona

9000

Universitair Ziekenhuis Gent, Ghent

13008

Hopital Saint Joseph, Marseille

20122

Irccs Ospedale Maggiore Di Milano, Milan

20146

ICH Study Center GmbH & Co. KG, Hamburg

28041

Hosp. Univ. 12 de Octubre, Madrid

28222

Hosp. Univ. Pta. de Hierro Majadahonda, Madrid

30625

Medizinische Hochschule Hannover, Hanover

35033

Chu Rennes Hopital Pontchaillou, Rennes

39008

Hosp. Univ. Marques de Valdecilla, Santander

41126

Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara, Modena

45147

Universitatsklinikum Essen, Essen

46014

Hosp. Gral. Univ. Valencia, Valencia

54511

CHU Nancy Brabois, Vandœuvre-lès-Nancy

55131

Universitatsmedizin der Johannes Gutenberg Universitat Mainz, Mainz

56124

Azienda Ospedaliero Universitaria Pisana, Pisa

60590

Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1, Frankfurt

69004

Hopital de La Croix Rousse, Lyon

75014

Hopital Cochin, Paris

79106

Universitatsklinikum Freiburg, Freiburg im Breisgau

92110

Hopital Beaujon, Clichy

94800

Hopital Paul Brousse, Villejuif

98124

Azienda Ospedaliera Universitaria Policlinico G. Martino, Messina

D-20246

University Medical Center, Hamburg

04103

Universitaetsklinikum Leipzig, Leipzig

00161

Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma, Rome

85-030

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy, Bydgoszcz

80-462

Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska, Gdansk

41-400

ID Clinic, Mysłowice

50-136

SP ZOZ Wroclawskie Centrum Zdrowia, Wroclaw

B15 2TH

Queen Elizabeth Hospital, Birmingham

M8 5RB

North Manchester General Hospital, Crumpsall

G31 2ER

Glasgow Royal Infirmary, Glasgow

E1 1BB

Grahame Hayton Unit, London

SE5 9RF

Kings College Hospital, London

SW17 0RE

St Georges University of London and St George's University Hospitals NHS Foundation Trust, London

All Listed Sponsors
lead

Janssen Sciences Ireland UC

INDUSTRY

NCT04129554 - 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 | Biotech Hunter | Biotech Hunter