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

April 9, 2025 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sebastian Marciano
        • Contact:
        • Contact:
  • Bulgaria
      • Sliven, Bulgaria, 8800
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dimitar Pavlov
        • Contact:
        • Contact:
      • Sofia, Bulgaria, 1431
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Diana Petrova
        • Contact:
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carla Coffin
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6R3
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wayne Ghesquiere
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jordan Feld
        • Contact:
        • Contact:
  • China
      • Hangzhou, China, 310000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guoping Sheng
      • Shanghai, China, 200025
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qing Xie
      • Wuhan, China, 430030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qin Ning
  • France
      • Clichy Cedex, France, 92110
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tarik Asselah
        • Contact:
        • Contact:
      • Strasbourg, France, 67200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lawrence SERFATY
        • Contact:
        • Contact:
  • Hong Kong
      • Pokfulam, Hong Kong
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Man Fung Yuen
        • Contact:
        • Contact:
  • Italy
      • Milano, Italy, 20122
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Pietro Lampertico
        • Contact:
        • Contact:
      • Milano, Italy, 20157
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Giuliano Rizzardini
        • Contact:
        • Contact:
      • Modena, Italy, 40126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pietro Andreone
  • Japan
      • Hiroshima, Japan, 730-8619
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nami Mori
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michio Imamura
      • Ishikawa, Japan, 920-8650
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Takuya Komura
        • Contact:
        • Contact:
      • Kagawa, Japan, 760-8557
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Koichi Takaguchi
      • Kumamoto, Japan, 862-8655
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shigetoshi Fujiyama
        • Contact:
        • Contact:
      • Miyagi, Japan, 980-8574
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jun Inoue
        • Contact:
        • Contact:
      • Osaka, Japan, 565-0871
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tetsuo Takehara
        • Contact:
        • Contact:
      • Tokyo, Japan, 113-8603
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masanori Atsukawa
      • Tokyo, Japan, 180-8610
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Masayuki Kurosaki
        • Contact:
        • Contact:
  • Korea, Republic of
      • Ansan-si Gyenggi-do, Korea, Republic of, 15355
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hyung Joon Yim
        • Contact:
        • Contact:
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sung-Jae Park
        • Contact:
        • Contact:
      • Pusan, Korea, Republic of, 49241
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jeong Heo
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Young-Suk Lim
        • Contact:
        • Contact:
  • Poland
      • Lublin, Poland, 20081
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Krzysztof Tomasiewicz
  • Romania
      • Craiova Dolj, Romania, 417307
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gheorghe Iulian Diaconescu
        • Contact:
        • Contact:
      • Galati, Romania, 800179
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Manuela Arbune
        • Contact:
        • Contact:
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454052
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Olga Sagalova
        • Contact:
        • Contact:
      • Krasnojarsk, Russian Federation, 660049
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Natalya Urievna Gankina
        • Contact:
        • Contact:
      • Moscow, Russian Federation, 121170
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tatyana Stepanova
        • Contact:
        • Contact:
      • Novosibirsk, Russian Federation, 630099
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Natalya B. Voloshina
        • Contact:
        • Contact:
      • Saint-Petersburg, Russian Federation, 191167
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Denis A. Gusev
        • Contact:
        • Contact:
      • Samara, Russian Federation, 443063
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vyacheslav Morozov
      • St Petersburg, Russian Federation, 190103
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Svetlana Romanova
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Seng-Gee Lim
        • Contact:
        • Contact:
      • Singapore, Singapore, 529889
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jessica Tan
        • Contact:
        • Contact:
  • South Africa
      • Durban, South Africa, 4091
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rosie Mngqibisa
        • Contact:
        • Contact:
      • Johannesburg, South Africa, 1830
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Agatha C Wilhase
        • Contact:
        • Contact:
  • Spain
      • Madrid, Spain, 28031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo Ryan Murua
      • Santander, Spain, 39008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Joaquín Cabezas Gonzalez
        • Contact:
        • Contact:
  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kittiyod Poovorawan
        • Contact:
        • Contact:
      • Kho Hong Hat Yai, Thailand, 90110
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Teerha Piratvisuth
        • Contact:
        • Contact:
  • United Kingdom
      • London, United Kingdom, WC1E 6JB
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Stuart Flanagan
        • Contact:
        • Contact:
      • Plymouth, United Kingdom, PL68DH
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Matthew Cramp
        • Contact:
        • Contact:
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Chak
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Raymond Taeyong Chung
        • Contact:
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stuart Gordon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

    1. 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
    2. 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

    1. 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
    2. 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
    3. 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

    1. 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
    2. 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.

Exclusion Criteria:

  • Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
  • Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Not-on-NA participants
Participants rolling over from study 209668 who have not received nucleos(t)ide analogue (NA) therapy during the parent study and remain off NAs will be included in this arm. Participants will be followed up for 33 months. Participants maintaining either functional cure (FC) or a partial response off NA treatment at Month 33 will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
Drug: Bepirovirsen
No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
Drug: Placebo
No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies.
Experimental: On-NA participants
Participants rolling over from studies 209668, 209348, 212602, 202009, 219288, and 217023 who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods in the parent study will be included in this arm. NA cessation will occur at 3 months in 206882 for eligible and willing participants. Participants will be followed up for 33 months. Participants rolling over from studies 209668 and 209348 who stopped NA treatment and are maintaining either FC or a partial response at Month 33, and remaining off NA treatment, will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
Drug: Bepirovirsen
No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
Drug: Placebo
No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies.
Experimental: NA-cessated participants
Participants rolling over from studies 202009 and 219288 who have stopped NA treatment during the parent study will be included in this arm. Participants will be followed up for 33 months. No study treatment will be administered in this study.
Drug: Bepirovirsen
No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
Drug: Placebo
No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO)
Time Frame: From primary endpoint assessment in the parent study up to Month 57
NA indicates nucleos(t)ide analogue (NA).
From primary endpoint assessment in the parent study up to Month 57
Percentage of On-NA participants rolling over from studies 209668 and 209348 without loss of functional cure (FC) after NA-cessation in study 206882
Time Frame: From Month 3 up to Month 57
From Month 3 up to Month 57
Percentage of On-NA participants rolling over from study 217023 without loss of FC after NA-cessation in study 206882
Time Frame: From Month 3 up to Month 33
From Month 3 up to Month 33
Percentage of NA-cessated participants rolling over from studies 202009 and 219288 without loss of FC after NA-cessation in the parent study
Time Frame: From primary endpoint assessment in the parent study up to Month 33
From primary endpoint assessment in the parent study up to Month 33

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have hepatitis B surface antigen (HBsAg) reversion or use of any rescue medication after NA cessation (in either parent study or study 206682)
Time Frame: Up to Month 57
Up to Month 57
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have virologic relapse or use of any rescue medication after NA cessation (in either parent study or study 206682)
Time Frame: Up to Month 57
Up to Month 57
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have clinical relapse or use of any rescue medication after NA cessation (in either parent study or study 206682)
Time Frame: Up to Month 57
Up to Month 57
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who receive NA retreatment after NA cessation (in either parent study or study 206682)
Time Frame: Up to Month 57
Up to Month 57
Percentage of On-NA participants with PSPO in the parent study, who continue NA treatment in study 206882, and have no loss of treatment response
Time Frame: From primary endpoint assessment in the parent study up to Month 33
From primary endpoint assessment in the parent study up to Month 33
Percentage of Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882 in absence of rescue medication after end of treatment in the parent study
Time Frame: Up to Month 57
Up to Month 57
Time to loss of FC from time of achieving delayed FC in Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882
Time Frame: From date of achieving delayed FC up to Month 57
From date of achieving delayed FC up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have a delayed FC in 206882 in absence of rescue medication after end of treatment in the parent study
Time Frame: Up to Month 57
Up to Month 57
Time to loss of FC in On-NA participants who achieve a partial response in the parent study, discontinue NA treatment in study 206882 and achieve delayed FC in 206882
Time Frame: From date of achieving delayed FC up to Month 57
From date of achieving delayed FC up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who do not discontinue NA treatment in study 206882, and have a delayed treatment response in 206882 in absence of rescue medication after end of treatment in the parent study
Time Frame: Up to Month 33
Up to Month 33
Time to loss of treatment response in On-NA participants who achieve a partial response in the parent study, do not discontinue NA treatment in study 206882 and have a delayed treatment response in 206882
Time Frame: From date of achieving delayed treatment response up to Month 33
From date of achieving delayed treatment response up to Month 33
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have HBsAg loss in the absence of any rescue medication after NA cessation in 206882
Time Frame: From Month 3 to Month 57
From Month 3 to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have virologic relapse or use of any rescue medication after NA cessation in 206882
Time Frame: From Month 3 up to Month 57
From Month 3 up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have clinical relapse or use of any rescue medication after NA cessation in 206882
Time Frame: From Month 3 up to Month 57
From Month 3 up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882 and have use of any rescue medication after NA cessation in 206882
Time Frame: From Month 3 up to Month 57
From Month 3 up to Month 57
Percentage of participants with anti-HBs (antibody to HBsAg)
Time Frame: Up to 57 months
Up to 57 months
Percentage of participants with anti-HBe (antibody to hepatitis B e-antigen [HBeAg])
Time Frame: Up to 57 months
Up to 57 months
Absolute values for HBsAg, hepatitis B virus (HBV) deoxyribonucleic acid (DNA), HBeAg (logarithm to the base 10 [log10] international units per milliliter [IU/mL])
Time Frame: Up to 57 months
Up to 57 months
Change from Baseline for HBsAg, HBV DNA, HBeAg (log10 IU/mL)
Time Frame: Baseline (End of Study visit in the parent study) and up to 57 months
Baseline (End of Study visit in the parent study) and up to 57 months
Absolute values for hepatitis B core-related antigen (HBcrAg) (kiloUnits per milliliter [kU/mL])
Time Frame: Up to 57 months
Up to 57 months
Change from Baseline for HBcrAg (kU/mL)
Time Frame: Baseline (End of Study visit in the parent study) and up to 57 months
Baseline (End of Study visit in the parent study) and up to 57 months
Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)
Time Frame: Up to 57 months
Up to 57 months
Change from Baseline for HBV RNA (log10 IU/ml)
Time Frame: Baseline (End of Study visit in the parent study) and up to 57 months
Baseline (End of Study visit in the parent study) and up to 57 months
Percentage of participants with mutations
Time Frame: Up to 57 months
Up to 57 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Estimated)

February 8, 2029

Study Completion (Estimated)

February 8, 2029

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206882
  • 2023-506867-33 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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