Long Term Follow-up Study in Participants Treated with JNJ-73763989 for Chronic HBV Infection

Last Updated   March 31, 2022 - 00:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    62 sites
  • Status
    Not yet recruiting

SUMMARY

The purpose of this study is to evaluate long-term Hepatitis B Surface Antigen (HBsAg) seroclearance in participants who completed one of the parent studies (example, REEF-1 [NCT03982186], REEF-2 [NCT04129554], INSIGHT [NCT04585789], REEF-IT [NCT04439539], PENGUIN [NCT04667104]) that included a regimen with JNJ-73763989 for the treatment of chronic Hepatitis B Virus (HBV) infection.

CONDITIONS

  • Hepatitis B

ELIGIBILITY

Inclusion Criteria:

  • • Participant was enrolled to and treated in one of the parent studies (example, REEF-1, REEF-2, INSIGHT, REEF-IT, PENGUIN and other qualifying studies that included a regimen with JNJ-3989 for the treatment of chronic HBV infection)
  • • Participant has completed the LVPS, and has not passed 24 weeks beyond the LVPS
  • • Participant must sign an informed consent form (ICF) for the current study indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

DETAILS

Participants may enroll in Lagoon study after completing one of the parent studies (eg, REEF-1, REEF-2, INSIGHT, REEF-IT, PENGUIN, and other qualifying studies that included a regimen with JNJ-73763989 [JNJ-3989]), which is ribonucleic acid interference (RNAi) for the treatment of chronic HBV infection. In the current study, long-term impact of a combination regimen including JNJ-3989, JNJ-56136379 (JNJ-6379), nucleos(t)ide analogs (NAs) and/or PegIFN, previously administered in 1 of the parent studies, will be assessed. This follow-up study will collect 144-week follow-up data to assess the rate of participants achieving HBsAg seroclearance beyond the follow-up period in the parent studies. During this long-term follow-up (LTFU) study, participants may continue, discontinue or re-start NA treatment as per investigator’s judgement, in line with local treatment guidelines. Assessment like patient-reported outcome(s) (PROs) assessments, electrocardiogram (ECG), vital signs, adverse events, laboratory test results, physical examination will be performed during the study. The duration of the study with long term follow-up is approximately 144 weeks.

LOCATIONS

Locations in:
United Kingdom, Turkey, Thailand, South Korea, Russia, Poland, Malaysia, Japan, Italy, Hong Kong, Germany, France, Belgium
Country (13) City or Province (62) Status
United Kingdom Glasgow NHS Greater Glasgow and Clyde
Not yet recruiting
United Kingdom London King's College Hospital NHS Foundation Trust
Not yet recruiting
United Kingdom London St George’s Healthcare NHS Trust
Not yet recruiting
United Kingdom Manchester Central Manchester University Hospitals NHS Foundation Trust
Not yet recruiting
United Kingdom Whitechapel Barts Health NHS Trust
Not yet recruiting
Turkey Ankara, ANK Hacettepe Universitesi Hastanesi
Not yet recruiting
Turkey Faith Istanbul University
Not yet recruiting
Turkey Mamak, ANK Ankara Universitesi Tip Fakultesi
Not yet recruiting
Turkey Trabzon, TRA Karadeniz Teknik University Medical Faculty Farabi Hospital
Not yet recruiting
Turkey zmir Ege Universitesi Tip Fakultesi
Not yet recruiting
Thailand Bangkok, 10 Faculty of Medicine Siriraj Hospital
Not yet recruiting
Thailand Bangkok, 10 King Chulalongkorn Memorial Hospital
Not yet recruiting
Thailand Chom Thong, 65 Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine
Not yet recruiting
Thailand Hat Yai, 90 Prince Of Songkla University
Not yet recruiting
South Korea Seoul Asan Medical Center
Not yet recruiting
South Korea Seoul Seoul National University Hospital
Not yet recruiting
South Korea Seoul Severance Hospital
Not yet recruiting
Russia Chelyabinsk Ural State Medical University
Not yet recruiting
Russia Krasnoyarsk Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
Not yet recruiting
Russia Moscow Clinic of the Modern Medicine
Not yet recruiting
Russia Novosibirsk Medical Center SibNovoMed LLC
Not yet recruiting
Russia Saint Petersburg Clinical Infectious Diseases Hospital n. a. S.P. Botkin
Not yet recruiting
Russia Saint Petersburg St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
Not yet recruiting
Russia Samara Medical Company Hepatolog Ltd
Not yet recruiting
Russia Smolensk Smolensk Regional Clinical Hospital
Not yet recruiting
Russia Stavropol Stavropol State Medical University
Not yet recruiting
Russia Yekaterinburg Sverdlovsk Regional Clinical Hospital N. 1
Not yet recruiting
Poland Gdansk Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
Not yet recruiting
Poland Myslowice ID Clinic
Not yet recruiting
Poland Warszawa Wojewodzki Szpital Zakazny w Warszawie
Not yet recruiting
Malaysia Alor Setar, KD Hospital Sultanah Bahiyah
Not yet recruiting
Malaysia Batu Caves, SL Hospital Selayang
Not yet recruiting
Malaysia Kota Bharu, KN Hospital University Sains Malaysia
Not yet recruiting
Malaysia Kuala Lumpur University Malaya Medical Center
Not yet recruiting
Japan Bunkyo-Ku, 13 Tokyo Medical and Dental University Medical Hospital
Not yet recruiting
Japan Chiba Chiba University Hospital
Not yet recruiting
Japan Fukui City Fukui-ken Saiseikai Hospital
Not yet recruiting
Japan Fukuyama Fukuyama City Hospital
Not yet recruiting
Japan Hiroshima Hiroshima University Hospital
Not yet recruiting
Japan Kagawa, 37 Kagawa Prefectural Central Hospital
Not yet recruiting
Japan Kashihara, 29 Nara Medical University Hospital
Not yet recruiting
Japan Musashino, 13 Musashino Red Cross Hospital
Not yet recruiting
Japan Nagasaki, 42 National Hospital Organization Nagasaki Medical Center
Not yet recruiting
Japan Nagoya Nagoya City University Hospital
Not yet recruiting
Japan Nishinomiya, 28 The Hospital of Hyogo College of Medicine
Not yet recruiting
Japan Sapporo, 01 Hokkaido University Hospital
Not yet recruiting
Japan Tokyo, 13 Toranomon Hospital
Not yet recruiting
Japan Toyoake Fujita Health University Hospital
Not yet recruiting
Italy Modena Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara
Not yet recruiting
Hong Kong Ma Liu Shui The Chinese University of Hong Kong
Not yet recruiting
Germany Berlin, BE EPIMED GmbH
Not yet recruiting
Germany Essen, NW Universitatsklinikum Essen
Not yet recruiting
Germany Frankfurt, HE Klinikum der Johann Wolfgang Goethe -Universitaet
Not yet recruiting
Germany Freiburg, BW Universitatsklinikum Freiburg
Not yet recruiting
Germany HAMBURG, HH ICH Study Center GmbH & Co. KG
Not yet recruiting
Germany Hannover Medizinische Hochschule Hannover
Not yet recruiting
France Clichy-Sous-Bois Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon
Not yet recruiting
France Grenoble Hôpital Michallon
Not yet recruiting
France LYON HOPITAL DE LA CROIX ROUSSE
Not yet recruiting
France Marseille Cedex 08 Hopital Saint Joseph
Not yet recruiting
France PARIS CEDEX 12 Hopital Saint-Antoine
Not yet recruiting
Belgium Edegem Universitair Ziekenhuis Antwerpen
Not yet recruiting
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