Long Term Follow-up Study in Participants Treated with JNJ-73763989 for Chronic HBV Infection
Last Updated   March 31, 2022 - 00:00
OVERVIEW
-
Gender
all -
Age
years -
Phase
phase 3The 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
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
Country (13) | City or Province (62) | Status |
United Kingdom | Glasgow NHS Greater Glasgow and Clyde |
Not yet recruiting
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United Kingdom | London King's College Hospital NHS Foundation Trust |
Not yet recruiting
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United Kingdom | London St George’s Healthcare NHS Trust |
Not yet recruiting
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United Kingdom | Manchester Central Manchester University Hospitals NHS Foundation Trust |
Not yet recruiting
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United Kingdom | Whitechapel Barts Health NHS Trust |
Not yet recruiting
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Turkey | Ankara, ANK Hacettepe Universitesi Hastanesi |
Not yet recruiting
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Turkey | Faith Istanbul University |
Not yet recruiting
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Turkey | Mamak, ANK Ankara Universitesi Tip Fakultesi |
Not yet recruiting
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Turkey | Trabzon, TRA Karadeniz Teknik University Medical Faculty Farabi Hospital |
Not yet recruiting
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Turkey | zmir Ege Universitesi Tip Fakultesi |
Not yet recruiting
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Thailand | Bangkok, 10 Faculty of Medicine Siriraj Hospital |
Not yet recruiting
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Thailand | Bangkok, 10 King Chulalongkorn Memorial Hospital |
Not yet recruiting
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Thailand | Chom Thong, 65 Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine |
Not yet recruiting
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Thailand | Hat Yai, 90 Prince Of Songkla University |
Not yet recruiting
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South Korea | Seoul Asan Medical Center |
Not yet recruiting
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South Korea | Seoul Seoul National University Hospital |
Not yet recruiting
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South Korea | Seoul Severance Hospital |
Not yet recruiting
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Russia | Chelyabinsk Ural State Medical University |
Not yet recruiting
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Russia | Krasnoyarsk Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis |
Not yet recruiting
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Russia | Moscow Clinic of the Modern Medicine |
Not yet recruiting
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Russia | Novosibirsk Medical Center SibNovoMed LLC |
Not yet recruiting
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Russia | Saint Petersburg Clinical Infectious Diseases Hospital n. a. S.P. Botkin |
Not yet recruiting
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Russia | Saint Petersburg St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis |
Not yet recruiting
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Russia | Samara Medical Company Hepatolog Ltd |
Not yet recruiting
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Russia | Smolensk Smolensk Regional Clinical Hospital |
Not yet recruiting
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Russia | Stavropol Stavropol State Medical University |
Not yet recruiting
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Russia | Yekaterinburg Sverdlovsk Regional Clinical Hospital N. 1 |
Not yet recruiting
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Poland | Gdansk Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska |
Not yet recruiting
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Poland | Myslowice ID Clinic |
Not yet recruiting
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Poland | Warszawa Wojewodzki Szpital Zakazny w Warszawie |
Not yet recruiting
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Malaysia | Alor Setar, KD Hospital Sultanah Bahiyah |
Not yet recruiting
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Malaysia | Batu Caves, SL Hospital Selayang |
Not yet recruiting
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Malaysia | Kota Bharu, KN Hospital University Sains Malaysia |
Not yet recruiting
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Malaysia | Kuala Lumpur University Malaya Medical Center |
Not yet recruiting
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Japan | Bunkyo-Ku, 13 Tokyo Medical and Dental University Medical Hospital |
Not yet recruiting
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Japan | Chiba Chiba University Hospital |
Not yet recruiting
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Japan | Fukui City Fukui-ken Saiseikai Hospital |
Not yet recruiting
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Japan | Fukuyama Fukuyama City Hospital |
Not yet recruiting
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Japan | Hiroshima Hiroshima University Hospital |
Not yet recruiting
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Japan | Kagawa, 37 Kagawa Prefectural Central Hospital |
Not yet recruiting
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Japan | Kashihara, 29 Nara Medical University Hospital |
Not yet recruiting
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Japan | Musashino, 13 Musashino Red Cross Hospital |
Not yet recruiting
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Japan | Nagasaki, 42 National Hospital Organization Nagasaki Medical Center |
Not yet recruiting
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Japan | Nagoya Nagoya City University Hospital |
Not yet recruiting
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Japan | Nishinomiya, 28 The Hospital of Hyogo College of Medicine |
Not yet recruiting
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Japan | Sapporo, 01 Hokkaido University Hospital |
Not yet recruiting
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Japan | Tokyo, 13 Toranomon Hospital |
Not yet recruiting
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Japan | Toyoake Fujita Health University Hospital |
Not yet recruiting
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Italy | Modena Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara |
Not yet recruiting
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Hong Kong | Ma Liu Shui The Chinese University of Hong Kong |
Not yet recruiting
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Germany | Berlin, BE EPIMED GmbH |
Not yet recruiting
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Germany | Essen, NW Universitatsklinikum Essen |
Not yet recruiting
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Germany | Frankfurt, HE Klinikum der Johann Wolfgang Goethe -Universitaet |
Not yet recruiting
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Germany | Freiburg, BW Universitatsklinikum Freiburg |
Not yet recruiting
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Germany | HAMBURG, HH ICH Study Center GmbH & Co. KG |
Not yet recruiting
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Germany | Hannover Medizinische Hochschule Hannover |
Not yet recruiting
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France | Clichy-Sous-Bois Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon |
Not yet recruiting
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France | Grenoble Hôpital Michallon |
Not yet recruiting
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France | LYON HOPITAL DE LA CROIX ROUSSE |
Not yet recruiting
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France | Marseille Cedex 08 Hopital Saint Joseph |
Not yet recruiting
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France | PARIS CEDEX 12 Hopital Saint-Antoine |
Not yet recruiting
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Belgium | Edegem Universitair Ziekenhuis Antwerpen |
Not yet recruiting
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