Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (REEF-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03982186
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Sciences Ireland UC

Brief Summary:
The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: JNJ-73763989 Drug: Placebo for JNJ-73763989 Drug: JNJ-56136379 Drug: Placebo for JNJ-56136379 Drug: Nucleos(t)ide Analog (NA) Phase 2

Detailed Description:
Hepatitis B virus (HBV) is a small deoxyribonucleic acid virus that specifically infects the human liver. The acute phase of infection is either followed by an immune controlled state or progresses to chronic hepatitis B. The worldwide estimated prevalence of chronic HBV infection is about 292 million people affected. Hepatitis B surface antigen (HBsAg) seroclearance is currently considered to be associated with the most thorough suppression of HBV replication (termed functional cure). With current available NA treatment strategies, rate of HBsAg seroclearance remains very low (around 3 percent [%]) even under long-term treatment. Also, with the persistently high global prevalence of HBV-associated mortality, there is a medical need for more effective finite treatment options that lead to sustained HBsAg seroclearance. JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for the treatment of chronic HBV infection. The aim of the study is to evaluate efficacy as measured by proportion of participants who completed 48-week study intervention and qualified for stopping NA treatment at Week 48. The study includes: Screening phase (4 weeks), Double-blind study intervention phase (from Day 1 up to Week 48), and Follow-up phase (48 weeks after end of investigational intervention with a maximum duration of 96 weeks). The duration of individual study participation will be between 100 and 150 weeks. Safety and tolerability (including adverse events [AEs] and Serious AEs, laboratory assessments, electrocardiogram [ECG], vital signs, physical examination), efficacy (including HBsAg seroclearance), and pharmacokinetics will be assessed throughout the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
Estimated Study Start Date : July 17, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : December 22, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NA
Participants will receive medium dose of JNJ-73763989 along with JNJ-56136379 and nucleos(t)ide analog (NA) treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide [TAF]) up to 48 weeks.
Drug: JNJ-73763989
JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.

Drug: JNJ-56136379
JNJ-56136379 tablets will be administered orally.

Drug: Nucleos(t)ide Analog (NA)
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.

Experimental: Arm 2: JNJ-73763989 (high dose) + Placebo + NA
Participants will receive high dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: JNJ-73763989
JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.

Drug: Placebo for JNJ-56136379
Placebo for JNJ-56136379 tablets will be administered orally.

Drug: Nucleos(t)ide Analog (NA)
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.

Experimental: Arm 3: JNJ-73763989 (medium dose) + Placebo + NA
Participants will receive medium dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: JNJ-73763989
JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.

Drug: Placebo for JNJ-56136379
Placebo for JNJ-56136379 tablets will be administered orally.

Drug: Nucleos(t)ide Analog (NA)
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.

Experimental: Arm 4: JNJ-73763989 (low dose) + Placebo + NA
Participants will receive low dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: JNJ-73763989
JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.

Drug: Placebo for JNJ-56136379
Placebo for JNJ-56136379 tablets will be administered orally.

Drug: Nucleos(t)ide Analog (NA)
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.

Experimental: Arm 5: Placebo + JNJ-56136379 + NA
Participants will receive placebo for JNJ-73763989 and a fixed dose of JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: Placebo for JNJ-73763989
Placebo for JNJ-73763989 will be administered as subcutaneous injection.

Drug: JNJ-56136379
JNJ-56136379 tablets will be administered orally.

Drug: Nucleos(t)ide Analog (NA)
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.

Placebo Comparator: Arm 6 (Control): Placebo + Placebo + NA
Participants will receive placebo for JNJ-73763989 and placebo for JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
Drug: Placebo for JNJ-73763989
Placebo for JNJ-73763989 will be administered as subcutaneous injection.

Drug: Placebo for JNJ-56136379
Placebo for JNJ-56136379 tablets will be administered orally.

Drug: Nucleos(t)ide Analog (NA)
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.




Primary Outcome Measures :
  1. Percentage of Participants Meeting the Nucleos(t)ide Analog (NA) Treatment Completion Criteria at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants meeting the NA treatment completion criteria at week 48 will be reported.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events (AE) and Serious Adverse Events (SAE) as a Measure of Safety and Tolerability [ Time Frame: Up to follow-up (maximum up to 150 weeks) ]
    An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. 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.

  2. Number of Participants with Abnormalities in Clinical Laboratory Tests, 12-Lead Electrocardiogram (ECG), and Vital Signs [ Time Frame: Up to follow-up (maximum up to 150 weeks) ]
    Number of participants with abnormalities in clinical laboratory tests, 12-lead ECG, and vital signs will be reported.

  3. Percentage of Participants with HBsAg Seroclearance After Completion of all Study Intervention [ Time Frame: Week 72 and Week 96 ]
    Percentage of participants with hepatitis B surface antigen (HBsAg) seroclearance after completion of all study intervention will be reported.

  4. Percentage of Participants with HBV DNA less than (<) Lower Limit of Quantification (LLOQ) After Completion of all Study Intervention [ Time Frame: Week 72 and Week 96 ]
    Percentage participants with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) <LLOQ after completion of all study intervention will be reported.

  5. Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up [ Time Frame: Up to 96 weeks ]
    Percentage of participants meeting the NA treatment completion criteria during follow-up will be reported.

  6. Percentage of Participants with HBsAg Seroclearance After Completion of NA Treatment at any Time During Follow-up [ Time Frame: Up to 150 weeks ]
    Percentage of participants with HBsAg seroclearance after completion of NA treatment at any time during follow-up will be reported.

  7. Percentage of Participants Requiring NA Re-treatment During Follow-up [ Time Frame: Up to 150 weeks ]
    Percentage of participants requiring NA re-treatment during follow-up will be reported.

  8. Percentage of Participants with Relapse [ Time Frame: Up to 150 weeks ]
    Percentage of participants with relapse will be reported.

  9. Percentage of Participants with (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Markers [ Time Frame: Up to Week 96 ]
    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.

  10. Percentage of Participants with HBsAg Seroconversion [ Time Frame: Up to 150 weeks ]
    Percentage of participants with HBsAg seroconversion will be reported.

  11. Percentage of Participants with HBeAg Seroconversion [ Time Frame: Up to 150 weeks ]
    Percentage of participants with HBeAg seroconversion will be reported.

  12. Change From Baseline in HBsAg Levels [ Time Frame: Baseline up to follow up (up to Week 150) ]
    Change from baseline in HBsAg levels will be determined.

  13. Change From Baseline in HBeAg Levels [ Time Frame: Baseline up to follow up (up to Week 150) ]
    Change from baseline in HBeAg levels will be determined.

  14. Change from Baseline in HBV DNA Levels [ Time Frame: Baseline up to follow up (up to Week 150) ]
    Change from baseline in HBV DNA levels will be determined.

  15. Time to Achieve HBsAg Seroclearance [ Time Frame: Up to Week 96 ]
    Time to achieve HBsAg seroclearance will be determined.

  16. Time to Achieve HBeAg Seroclearance [ Time Frame: Up to Week 96 ]
    Time to achieve HBeAg seroclearance will be determined.

  17. Percentage of Participants with <100 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline [ Time Frame: Baseline up to Week 150 ]
    Percentage of participants with less than (<) 100 international units per milliliter (IU/mL) or greater than (>) 1 log10 IU/mL reduction in HBsAg from baseline will be assessed.

  18. Percentage of HBeAg-positive Participants with HBeAg Levels [ Time Frame: Baseline up to Week 150 ]
    Percentage of HBeAg-positive participants with HBeAg levels will be reported.

  19. Percentage of Participants with ALT Decrease and Normalization [ Time Frame: Up to follow-up (maximum up to 150 weeks) ]
    Percentage of participants with alanine aminotransferase (ALT) decrease and normalization will be reported.

  20. Percentage of Participants with Virologic Breakthrough [ Time Frame: Up to Week 48 ]
    Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by >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.

  21. Percentage of Participants with Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up [ Time Frame: Up to 150 weeks ]
    Percentage of participants who reach HBV DNA undetectability after re-start of NA treatment during follow-up will be reported.

  22. Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-73763989 [ Time Frame: Days 1, 29, 85, 169 and 337 ]
    The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.

  23. Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-56136379 [ Time Frame: Days 1, 29, 85, 169 and 337 ]
    The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.

  24. Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of NA [ Time Frame: Days 1, 29, 85, 169 and 337 ]
    The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  • 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
  • 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
  • Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
  • Male participants who plan to father a child while enrolled
  • Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
  • Vulnerable participants (example, incarcerated individuals)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982186


Contacts
Layout table for location contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

  Hide Study Locations
Locations
Layout table for location information
United States, California
The Office of Franco Felizarta, MD Not yet recruiting
Bakersfield, California, United States, 93301
Ruane Clinical Research Group Inc Not yet recruiting
Los Angeles, California, United States, 90036
Southern California GI and Liver Center Not yet recruiting
San Clemente, California, United States, 92673
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
I.D. Care, Inc. Not yet recruiting
Hillsborough, New Jersey, United States, 08844
United States, New York
NYU Hepatology Associates Not yet recruiting
New York, New York, United States, 10016
Belgium
SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg) Not yet recruiting
Antwerpen, Belgium, 2060
Cliniques Universitaires Saint-Luc Not yet recruiting
Brussel, Belgium, 1200
UZ Antwerpen Not yet recruiting
Edegem, Belgium, 2650
Universitair Ziekenhuis Gent Not yet recruiting
Gent, Belgium, 9000
UZ Leuven Not yet recruiting
Leuven, Belgium, 3000
Brazil
Instituto AZ de Ensino e Pesquisa Not yet recruiting
Curitiba, Brazil, 80240-280
Fundação De Medicina Tropical Doutor Heitor Vieira Dourado Not yet recruiting
Manaus, Brazil, 69040-000
Hospital das Clinicas da Universidade Federal da Bahia Not yet recruiting
Salvador, Brazil, 40110-060
Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo Not yet recruiting
Sao Paulo, Brazil, 05403-000
Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta - Faculty of Medicine & Dentistry Not yet recruiting
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
GI Research Institute (G.I.R.I.) Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Vancouver ID Research and Care Centre Society Not yet recruiting
Vancouver, British Columbia, Canada, V6Z2C7
Canada
Toronto General Hospital Not yet recruiting
Toronto, Canada, ON M5G 2C4
China
Nanfang Hospital Not yet recruiting
Guangzhou, China, 510515
Huashan Hospital Fudan University Not yet recruiting
Shanghai, China, 200040
Czechia
FN Hradec Kralove Not yet recruiting
Hradec Kralove, Czechia, 500 05
FN Plzen Not yet recruiting
Plzen, Czechia, 304 60
KLIN MED s.r.o Not yet recruiting
Praha 2, Czechia, 120 00
IKEM Not yet recruiting
Praha, Czechia, 140 21
France
Hôpital Beaujon Not yet recruiting
Clichy, France, 92110
CHU de Grenoble - Hôpital Albert Michallon Not yet recruiting
Grenoble, France, 38043
Hopital de La Croix Rousse Not yet recruiting
Lyon, France, 69004
Hopital Saint Joseph Not yet recruiting
Marseille, France, 13008
CHU de Nantes hôtel-Dieu Not yet recruiting
Nantes, France, 44093
Hopital Saint-Antoine Not yet recruiting
Paris, France, 75012
Chu Rennes - Hopital Pontchaillou Not yet recruiting
Rennes, France, 35033
Hopital Paul Brousse Not yet recruiting
Villejuif, France, 94800
Germany
EPIMED GmbH Not yet recruiting
Berlin, Germany, 12157
Universitatsklinikum Essen Not yet recruiting
Essen, Germany, 45147
Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1 Not yet recruiting
Frankfurt, Germany, 60590
Universitatsklinikum Freiburg Not yet recruiting
Freiburg, Germany, 79106
ICH Study Center GmbH & Co. KG Not yet recruiting
Hamburg, Germany, 20146
University Medical Center Not yet recruiting
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Germany, 30625
Universitatsklinikum Leipzig Not yet recruiting
Leipzig, Germany, 04103
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Not yet recruiting
Mainz, Germany, 55121
Hong Kong
The University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong
The Chinese University of Hong Kong Not yet recruiting
Shatin, Hong Kong
Italy
Policlinico Sant'Orsola Malpighi Not yet recruiting
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Policlinico G. Martino Not yet recruiting
Messina, Italy, 98124
Irccs Ospedale Maggiore Di Milano Not yet recruiting
Milano, Italy, 20122
Azienda Ospedaliero Universitaria Pisana Not yet recruiting
Pisa, Italy, 56124
Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma Not yet recruiting
Rome, Italy, 00161
Japan
Medical Hospital, Tokyo Medical and Dental University Not yet recruiting
Bunkyo-ku, Japan, 113-8519
Chiba University Hospital Not yet recruiting
Chiba, Japan, 260-8677
Fukui-ken Saiseikai Hospital Not yet recruiting
Fukui City, Japan, 918-8503
Fukuyama City Hospital Not yet recruiting
Fukuyama, Japan, 721-8511
Hiroshima University Hospital Not yet recruiting
Hiroshima, Japan, 734-8551
Kagawa Prefectural Central Hospital Not yet recruiting
Kagawa, Japan, 760-8557
Nara Medical University Hospital Not yet recruiting
Kashihara, Japan, 634-8522
Musashino Red Cross Hospital Not yet recruiting
Musashino, Japan, 180-8610
NHO Nagasaki Medical Center Not yet recruiting
Nagasaki, Japan, 856-8562
Nagoya City University Hospital Not yet recruiting
Nagoya, Japan, 467-8602
Hyogo College of Medicine Hospital Not yet recruiting
Nishinomiya, Japan, 663-8501
Osaka University Hospital Not yet recruiting
Osaka, Japan, 565-0871
Hokkaido University Hospital Not yet recruiting
Sapporo-shi, Japan, 060-8648
Toranomon Hospital Not yet recruiting
Tokyo, Japan, 105-8470
Fujita Health University Hospital Not yet recruiting
Toyoake, Japan, 470-1192
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 06351
Malaysia
Hospital Sultanah Bahiyah Not yet recruiting
Alor Setar, Malaysia, 05460
Hospital Selayang Not yet recruiting
Batu Caves, Malaysia, 68100
Hospital University Sains Malaysia Not yet recruiting
Kota Bharu, Malaysia, 16150
University Malaya Medical Centre Not yet recruiting
Kuala Lumpur, Malaysia, 59120
Poland
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy Not yet recruiting
Bydgoszcz, Poland, 85-030
Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska Not yet recruiting
Gdansk, Poland, 80-462
ID Clinic Not yet recruiting
Myslowice, Poland, 41-400
Wojewodzki Szpital Zakazny w Warszawie Not yet recruiting
Warszawa, Poland, 01-201
SP ZOZ Wroclawskie Centrum Zdrowia Not yet recruiting
Wroclaw, Poland, 50-136
Russian Federation
Ural State Medical University Not yet recruiting
Chelyabinsk, Russian Federation, 454092
Sverdlovsk Regional Clinical Hospital #1 Not yet recruiting
Ekaterinburg, Russian Federation, 620102
Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis Not yet recruiting
Krasnoyarsk, Russian Federation, 660049
Clinic of the Modern Medicine Not yet recruiting
Moscow, Russian Federation, 121170
Medical Center 'SibNovoMed' LLC Not yet recruiting
Novosibirsk, Russian Federation, 630005
St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis Not yet recruiting
Saint Petersburg, Russian Federation, 190103
Republican Clinical Infectious Hospital Not yet recruiting
Saint Petersburg, Russian Federation, 196645
Clinical Infectious Diseases Hospital n. a. S.P. Botkin Not yet recruiting
Saint-Petersburg, Russian Federation, 195067
Medical Company 'Hepatolog' Ltd Not yet recruiting
Samara, Russian Federation, 443063
Smolensk Regional Clinical Hospital Not yet recruiting
Smolensk, Russian Federation, 214018
Stavropol State Medical University Not yet recruiting
Stavropol, Russian Federation, 355017
Spain
Hosp. Clinic I Provincial de Barcelona Not yet recruiting
Barcelona, Spain, 08028
Hosp. Univ. Vall D Hebron Not yet recruiting
Barcelona, Spain, 08035
Hosp. Univ. 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Hospital Puerta De Hierro Not yet recruiting
Madrid, Spain, 28222
Hosp. Univ. Marques de Valdecilla Not yet recruiting
Santander, Spain, 39008
Hosp. Gral. Univ. Valencia Not yet recruiting
Valencia, Spain, 46014
Thailand
King Chulalongkorn Memorial Hospital Not yet recruiting
Bangkok, Thailand, 10500
Siriraj Hospital Not yet recruiting
Bangkok, Thailand, 10700
Chiang Mai University Hospital Not yet recruiting
Chiang Mai, Thailand, 50200
Prince Of Songkla University Not yet recruiting
Songkla, Thailand, 90110
Turkey
Hacettepe University Hospital Not yet recruiting
Ankara, Turkey, 06230
Ankara University Medical Faculty Not yet recruiting
Ankara, Turkey, 06620
Yildirim Beyazıt University Ataturk Training and Research Hospital Not yet recruiting
Ankara, Turkey, 06800
Istanbul University Cerrahpasa Medical Faculty Not yet recruiting
Istanbul, Turkey, 34098
Ege University Medical of Faculty, Department of Gastroenterology Not yet recruiting
İzmir, Turkey, 35100
Karadeniz Teknik University Medical Faculty Not yet recruiting
Trabzon, Turkey, 61080
United Kingdom
NHS Greater Glasgow and Clyde - Gartnavel General Hospital Not yet recruiting
Glasgow, United Kingdom, G12 0YN
Grahame Hayton Unit Not yet recruiting
London, United Kingdom, E1 1BB
Kings College Hospital Not yet recruiting
London, United Kingdom, SE5 9RF
St George's, University of London and St George's University Hospitals NHS Foundation Trust Not yet recruiting
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
Janssen Sciences Ireland UC
Investigators
Layout table for investigator information
Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC

Layout table for additonal information
Responsible Party: Janssen Sciences Ireland UC
ClinicalTrials.gov Identifier: NCT03982186     History of Changes
Other Study ID Numbers: CR108608
2019-000622-22 ( EudraCT Number )
73763989HPB2001 ( Other Identifier: Janssen Sciences Ireland UC )
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Virus Diseases
Herpesviridae Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections