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NCT04954859Active, not recruitingPhase 2

Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)

A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Treatment Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Participated in a Previous Bepirovirsen Treatment Study

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent bepirovirsen studies (studies B-Clear \[209668: NCT04449029\], B-Together \[209348: NCT04676724\], B-Fine \[212602: NCT04544956\], B-Well 1 \[202009: NCT05630807\], B-Well 2 \[219288: NCT05630820\], and TH HBV ASO-001 \[217023: NCT05276297\]). Participants will be categorized as Not-on-NA, NA-cessated, or On-NA based on their nucleos(t)ide analogue (NA) status in the parent study. No further treatment with bepirovirsen will be administered in this study.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
366 (actual)
First submitted
29 Jun 2021
Start date
14 Dec 2021
Primary completion date
24 Jan 2029
Lead sponsor
GlaxoSmithKline
Diseases
Hepatitis B
NCT number
NCT04954859
EU CT number
2023-506867-33-01
EudraCT number
2021-000554-26

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 366
  • From 14 Dec 2021 to the primary completion date, 24 Jan 2029
  • 146 sites in 29 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.

Other illness

  • Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Who the study is looking for

  • Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule.
  • Capable of giving informed consent.
    • For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine):
  • Participants who have previously received at least one dose of bepirovirsen AND
    • Achieved the PSPO in the parent study and who maintained a response until the End of Study (EoS) visit in their parent study (defined as complete responders to bepirovirsen from the parent study) OR
    • Demonstrated hepatitis B virus surface antigen (HBsAg) reduction greater than or equal to (≥) 1.0 log10 international units per milliliter (IU/mL) from parent study Baseline with HBsAg levels less than (\<) 100 IU/mL and HBV deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ) for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study.
    • For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2):
  • Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where appropriate) AND
    • NA cessated at Week 48 in parent study and achieved at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at the EOS visit (Week 96) in the parent study OR
    • Achieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at EOS visit (Week 72) of parent study OR
    • Did not achieve NA cessation criteria in parent study but achieved at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at EOS visit (Week 72) of parent study.
    • For participants rolling over from 217023 (TH HBV ASO-001):
  • Participants who have previously received at least 1 dose of bepirovirsen AND
    • Achieved HBsAg \<1 IU/ml and HBV DNA \<LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO 24 arm) and are maintaining HBsAg \< 1 IU/ml and HBV DNA \<LLOQ, at the EOS study visit \[Week 133 ASO12 arm), or Week 145 (ASO24 arm)\] in parent study OR
    • Did not achieve HBsAg \<1 IU/ml and HBV DNA \<LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO24 arm) but have achieved HBsAg \< 1 IU/ml and HBV DNA \< LLOQ by the EOS visit (Week 133 (ASO12 arm) or Week 145 (ASO24 arm)) in the parent study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (146)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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La PlataArgentinaUnknown status
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RosarioArgentinaUnknown status
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Santa FeArgentinaUnknown status
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FitzroyAustraliaUnknown status
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HerstonAustraliaUnknown status
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
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PlovdivBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
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SlivenBulgariaActive, not recruiting
Military Medical Academy
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SofiyaBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment Sofiamed OOD
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SofiyaBulgariaActive, not recruiting
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaActive, not recruiting
Diagnostics-Consultancy Center Mladost M Varna OOD
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VarnaBulgariaActive, not recruiting
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AracajuBrazilUnknown status
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CampinasBrazilUnknown status
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CuritibaBrazilUnknown status
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ManausBrazilUnknown status
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São PauloBrazilUnknown status
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Vila MarianaBrazilUnknown status
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CalgaryCanadaUnknown status
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MontrealCanadaUnknown status
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QuébecCanadaUnknown status
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TorontoCanadaUnknown status
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VictoriaCanadaUnknown status
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BeijingChinaUnknown status
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ChengduChinaUnknown status
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ChongqingChinaUnknown status
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FuzhouChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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KunmingChinaUnknown status
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ShanghaiChinaUnknown status
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ShenzhenChinaUnknown status
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TianjinChinaUnknown status
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ÜrümqiChinaUnknown status
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WuhanChinaUnknown status
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XiamenChinaUnknown status
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Xi'anChinaUnknown status
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ZhenjiangChinaUnknown status
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ZunyiChinaUnknown status
Infektiologisches Zentrum Steglitz (IZS)
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BerlinGermanyActive, not recruiting
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
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BerlinGermanyActive, not recruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyActive, not recruiting
Praxis MainFachArzt
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FrankfurtGermanyActive, not recruiting
ICH Study Center Gmbh & Co. KG
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HamburgGermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario De Leon
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LeónSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
Hospital Universitario Infanta Leonor
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MadridSpainActive, not recruiting
Complexo Hospitalario Universitario de Pontevedra
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PontevedraSpainActive, not recruiting
Parc Tauli Hospital Universitari
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SabadellSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Assistance Publique Hopitaux De Paris
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ClichyFranceActive, not recruiting
Centre Hospitalier Intercommunal Créteil
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CréteilFranceActive, not recruiting
Hospices Civils De Lyon
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Lyon Cedex 04FranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceActive, not recruiting
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CottinghamUnited KingdomUnknown status
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LiverpoolUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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PlymouthUnited KingdomUnknown status
Evaggelismos Hospital
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AthensGreeceActive, not recruiting
University General Hospital of Heraklion
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HeraklionGreeceActive, not recruiting
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KowloonHong Kong SAR ChinaUnknown status
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PokfulamHong Kong SAR ChinaUnknown status
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
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Budapest IXHungaryActive, not recruiting
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BelagaviIndiaUnknown status
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CoimbatoreIndiaUnknown status
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HyderabadIndiaUnknown status
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Kanchan Bagh HyderabadIndiaUnknown status
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MumbaiIndiaUnknown status
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New DelhiIndiaUnknown status
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PuneIndiaUnknown status
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SuratIndiaUnknown status
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
ASST Fatebenefratelli Sacco
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MilanItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
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GifuJapanUnknown status
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HiroshimaJapanUnknown status
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HokkaidoJapanUnknown status
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IshikawaJapanUnknown status
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KagawaJapanUnknown status
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KumamotoJapanUnknown status
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MiyagiJapanUnknown status
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NiigataJapanUnknown status
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OsakaJapanUnknown status
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TokyoJapanUnknown status
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YamaguchiJapanUnknown status
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Ansan-si Gyenggi-doSouth KoreaUnknown status
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BusanSouth KoreaUnknown status
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PusanSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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Kuala TerengganuMalaysiaUnknown status
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AucklandNew ZealandUnknown status
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Panama CityPanamaUnknown status
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Cebu CityPhilippinesUnknown status
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SilangPhilippinesUnknown status
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
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CracowPolandActive, not recruiting
Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p.
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GdanskPolandActive, not recruiting
Centrum Medyczne W Lancucie Sp. z o.o.
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LancutPolandActive, not recruiting
HEPID Diagnostyka i Terapia
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LublinPolandActive, not recruiting
ID Clinic
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MyslowicePolandActive, not recruiting
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
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BucharestRomaniaActive, not recruiting
Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"
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BucharestRomaniaActive, not recruiting
Spitalul Clinic Colentina Bucuresti
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BucharestRomaniaActive, not recruiting
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova
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CraiovaRomaniaActive, not recruiting
Clinic Hospital For Infectious Diseases Sf. Cuvioasa Parascheva Galati
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GalatiRomaniaActive, not recruiting
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi
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JassiRomaniaActive, not recruiting
Pelican Impex S.R.L.
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OradeaRomaniaActive, not recruiting
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ChelyabinskRussiaUnknown status
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MoscowRussiaUnknown status
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NovosibirskRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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SamaraRussiaUnknown status
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КрасноярскRussiaUnknown status
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SingaporeSingaporeUnknown status
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BangkokThailandUnknown status
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Chiang MaiThailandUnknown status
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Kho Hong Hat YaiThailandUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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Taipei CountyTaiwanUnknown status
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TaoyuanTaiwanUnknown status
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BostonUnited StatesUnknown status
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Colorado SpringsUnited StatesUnknown status
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DetroitUnited StatesUnknown status
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SacramentoUnited StatesUnknown status
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San JoseUnited StatesUnknown status
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DurbanSouth AfricaUnknown status
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JohannesburgSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.