An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

232

Participants

Timeline

Start Date

February 13, 2018

Primary Completion Date

September 5, 2019

Study Completion Date

August 13, 2020

Conditions
Hepatitis B
Interventions
DRUG

JNJ-56136379

Participants will receive JNJ-56136379 tablet orally.

DRUG

Placebo

Participants will receive matching placebo tablet orally.

DRUG

NA (ETV or TDF)

Participants will receive NA (ETV or TDF) tablet orally as per approved label.

Trial Locations (76)

333

Chang Gung Memorial Hospital Linkou Branch, Taoyuan District

1200

Cliniques Universitaires Saint-Luc, Brussels

2060

SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg), Antwerp

2650

UZ Antwerpen, Edegem

8028

Hosp. Clinic I Provincial de Barcelona, Barcelona

8035

Hosp. Univ. Vall D Hebron, Barcelona

10016

NYU Hepatology Associates, New York

10439

Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH, Berlin

10500

King Chulalongkorn Memorial Hospital, Bangkok

10700

Siriraj Hospital, Bangkok

15213

UPMC Center For Liver Diseases, Pittsburgh

20099

Asklepios Klinik St. Georg, Haus Lifi - Studien und Projekte GmbH, Hamburg

20122

Irccs Ospedale Maggiore Di Milano, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

21021

Vinnytsia City Clinical Hospital #1, Department of Infectious Diseases #1, Vinnytsia

28034

Hosp. Univ. Ramon Y Cajal, Madrid

32803

Orlando Immunology Center, Orlando

34098

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34371

Saglık Bilimleri University Şişli Trainig and Research Hospital,Department of Gastroenterology, Istanbul

35100

Ege University Medical of Faculty, Department of Gastroenterology, Izmir

39008

Hosp. Univ. Marques de Valdecilla, Santander

40705

Taichung Veterans General Hospital, Taichung

41013

Hosp. Virgen Del Rocio, Seville

45122

Universitatsklinikum Essen, Essen

49241

Pusan National University Hospital, Busan

50200

Chiang Mai University Hospital, Chiang Mai

56124

Azienda Ospedaliero Universitaria Pisana, Pisa

59100

University Malaya Medical Centre, Kuala Lumpur

60590

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

60612

Rush University Medical Center, Chicago

61000

Kharkiv National Medical University, Regional Clinical Infectious Hospital, Kharkiv

61039

SE 'National institute therapy named L.T. Maloi NAMS of Ukraine', Kharkiv

61080

Karadeniz Teknik University Medical Faculty, Trabzon

65025

Odessa Regional Clinical Hospital, Odesa

69004

Hopital de La Croix Rousse, Lyon

70112

Tulane Medical Center (TMC), New Orleans

70403

National Cheng Kung University Hospital, Tainan City

75012

Hopital Saint-Antoine, Paris

80756

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

90110

Prince Of Songkla University, Songkhla

92110

Hôpital Beaujon, Clichy

93301

The Office of Franco Felizarta, MD, Bakersfield

94800

Hopital Paul Brousse, Villejuif

100034

Peking University People's Hospital, Beijing

100050

Beiijing Friendship Hospital, Capital Medical University, Beijing

130021

The First Hospital of Jilin University, Changchun

355017

Stavropol State Medical University, Stavropol

443063

Medical Company Hepatolog Ltd, Samara

510515

Nanfang Hospital, Guangzhou

620102

Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

630005

Medical Center SibNovoMed LLC, Novosibirsk

08844

I.D. Care, Inc., Hillsborough

T2N 1N4

University of Calgary, Calgary

V6Z 2C7

Vancouver ID Research and Care Centre Society, Vancouver

V6Z 2K5

GI Research Institute (G.I.R.I.), Vancouver

H3H 2R9

McGill University Health Centre, Montreal

ON M5G 2C4

Toronto General Hospital, Toronto

Unknown

Queen Mary Hospital, University of Hong Kong, Hong Kong

The Chinese University of Hong Kong, Shatin

734-8551

Hiroshima University Hospital, Hiroshima

180-8610

Musashino Red Cross Hospital, Musashino

856-8562

National Hospital Organization Nagasaki Medical Center, Nagasaki

467-8602

Nagoya City University Hospital, Nagoya

565-0871

Osaka University Hospital, Suita-shi

05460

Hospital Sultanah Bahiyah, Alor Star

41-500

Szpital Specjalistyczny w Chorzowie, Chorzów

25-317

Wojewodzki Szpital Zespolony, Kielce

41-400

ID Clinic, Mysłowice

50-136

SP ZOZ Wroclawskie Centrum Zdrowia, Wroclaw

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

M8 5RB

North Manchester General Hospital, Crumpsall

E1 1BB

Grahame Hayton Unit, London

NE7 7DN

Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

All Listed Sponsors
lead

Janssen Sciences Ireland UC

INDUSTRY

NCT03361956 - An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection | Biotech Hunter | Biotech Hunter