Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)

November 6, 2023 updated by: GlaxoSmithKline

A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study

This is a long-term follow-up study to assess durability of efficacy, as measured by SVR, in participants who have received prior treatment with GSK3228836 and achieved a complete or partial response. No further treatment with GSK3228836 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
      • Beijing, China, 100069
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xinyue Chen
        • Contact:
        • Contact:
      • Beijing, China, 100050
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jidong Jia
      • Beijing, China, 100015
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yao Xie
      • Guangzhou, China, 510000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jinlin Hou
        • Contact:
        • Contact:
      • 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
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qin Ning
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun-Qi Niu
  • France
      • Clichy, 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
    • Emilia-Romagna
      • Baggiovara (MO), Emilia-Romagna, Italy, 40126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pietro Andreone
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Pietro Lampertico
        • Contact:
        • Contact:
      • Milano, Lombardia, Italy, 20132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Massimo Memoli
      • Milano, Lombardia, Italy, 20157
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Giuliano Rizzardini
        • Contact:
        • Contact:
  • Japan
      • Ehime, Japan, 790-8524
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kouji Joko
        • Contact:
        • Contact:
      • Gifu, Japan, 500-8717
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shogo Shimizu
      • Hiroshima, Japan, 737-0023
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hiroshi Kohno
        • Contact:
        • Contact:
      • 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:
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yasuhito Tanaka
      • Miyagi, Japan, 980-8574
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jun Inoue
        • Contact:
        • Contact:
      • Nagasaki, Japan, 856-8562
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Atsumasa Komori
      • 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
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jeong Heo
        • Contact:
        • Contact:
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sung-Jae Park
        • Contact:
        • Contact:
      • Gyeonggi-do, Korea, Republic of, 15355
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hyung Joon Yim
        • Contact:
        • Contact:
      • Incheon, Korea, Republic of, 405-760
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ju Hyun Kim
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Young-Suk Lim
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yoon Jun Kim
        • Contact:
        • Contact:
      • Ulsan, Korea, Republic of, 44033
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Neung Hwa Park
        • Contact:
        • Contact:
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruveena Bhavani
  • Poland
      • Lancut, Poland, 37-100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Robert Plesniak
        • Contact:
        • Contact:
      • Lublin, Poland, 20081
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Krzysztof Tomasiewicz
  • Romania
      • Craiova, 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
      • Barnaul, Russian Federation, 656010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valeriy Shevchenko
      • 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:
    • Gauteng
      • Ennerdale, Gauteng, 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
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joaquín Cabeza González
  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anchalee Avihingsanon
        • Contact:
        • Contact:
      • Bangkok, Thailand, 10400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abhasnee Sobhonslidsuk
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Apinya Leerapun
        • Contact:
        • Contact:
      • Hat Yai, Thailand, 90110
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Teerha Piratvisuth
        • Contact:
        • Contact:
      • Phitsanulok, Thailand, 65000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ekawee Sripariwuth
  • 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 have previously received at least one dose of GSK3228836 and

    1. Achieved SVR (defined as HBsAg and HBV DNA < lower limit of quantification (LLOQ) from end of previous investigational treatment until the End of study (EoS) visit in the previous treatment study (complete responder) OR
    2. Participants who have previously received at least one dose of GSK3228836 and demonstrated a partial response to GSK3228836 in the previous treatment study
  • Participants who enter the study on stable NA must be willing to discontinue NA treatment in accordance with the NA discontinuation schedule.
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with GSK3228836.
  • 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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nucleos(t)ide analogue (NA) naïve participants
Participants who have not received NA therapy during the parent study. No study treatment will be administered in this study.
Drug: GSK3228836
No study drug will be administered in this study. Eligible participants who received prior treatment with GSK3228836 in the parent studies will be included.
Experimental: NA controlled participants
Participants who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods. NA cessation at 3 months. No study treatment will be administered in this study.
Drug: GSK3228836
No study drug will be administered in this study. Eligible participants who received prior treatment with GSK3228836 in the parent studies will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from achieving SVR in previous GSK3228836 treatment study to loss of SVR (1st occurrence of either hepatitis B surface antigen or hepatitis B virus deoxyribonucleic acid [DNA] reversion, or 1st use of any rescue medication)-NA naïve participants
Time Frame: From primary endpoint assessment in the previous GSK3228836 study up to End of Study (Month 33)
NA indicates Nucleos(t)ide analogue (NA)
From primary endpoint assessment in the previous GSK3228836 study up to End of Study (Month 33)
Time from NA cessation to the loss of SVR-NA controlled participants
Time Frame: From Visit 3 (Month 3) up to End of Study (Month 33)
From Visit 3 (Month 3) up to End of Study (Month 33)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from NA cessation to the first occurrence of hepatitis B surface antigen (HBsAg) reversion or first use of any rescue medication- NA controlled participants
Time Frame: From Visit 3 (Month 3) up to End of Study (Month 33)
From Visit 3 (Month 3) up to End of Study (Month 33)
Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants
Time Frame: From Visit 3 (Month 3) up to End of Study (Month 33)
From Visit 3 (Month 3) up to End of Study (Month 33)
Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication
Time Frame: From Visit 3 (Month 3) up to End of Study (Month 33)
From Visit 3 (Month 3) up to End of Study (Month 33)
Time from NA cessation to NA retreatment- NA controlled participants
Time Frame: From Visit 3 (Month 3) up to End of Study (Month 33)
From Visit 3 (Month 3) up to End of Study (Month 33)
Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR- NA controlled participants
Time Frame: From primary endpoint assessment in the previous GSK 3228836 study up to End of Study (Month 33)
From primary endpoint assessment in the previous GSK 3228836 study up to End of Study (Month 33)
Percentage of participants with delayed SVR in absence of rescue medication after the end of parent study- NA naïve participants
Time Frame: Months 0, 3, 9, 15, 21, 27, 33
Months 0, 3, 9, 15, 21, 27, 33
Time to the loss of SVR from time of achieving delayed SVR (NA naïve participants achieving delayed SVR)
Time Frame: From date of achieving SVR up to End of Study (Month 33)
From date of achieving SVR up to End of Study (Month 33)
Percentage of participants with delayed SVR in the absence of any rescue medication after end of the parent study (NA controlled participants continuing NA treatment)
Time Frame: Months 0, 2.5, 9, 15, 21, 27, 33
Months 0, 2.5, 9, 15, 21, 27, 33
Time to the loss of SVR from time of achieving delayed SVR (NA controlled participants continuing NA treatment)
Time Frame: From date of achieving SVR up to End of Study (Month 33)
From date of achieving SVR up to End of Study (Month 33)
Percentage of participants with delayed SVR, in the absence of NA retreatment after NA cessation (NA controlled participants who have discontinued NA treatment)
Time Frame: Months 6, 9, 15, 21, 27, 33
Months 6, 9, 15, 21, 27, 33
Time to the loss of SVR from time of achieving SVR (NA controlled participants who have discontinued NA treatment)
Time Frame: From date of achieving SVR up to End of Study (Month 33)
From date of achieving SVR up to End of Study (Month 33)
Percentage of participants with HBsAg loss in the absence of any rescue medication after NA cessation- NA controlled participants with partial response
Time Frame: Months 6, 9, 15, 21, 27, 33
Months 6, 9, 15, 21, 27, 33
Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants with partial response
Time Frame: From Visit 3 (Month 3) up to End of Study (Month 33)
From Visit 3 (Month 3) up to End of Study (Month 33)
Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication- NA controlled participants with partial response
Time Frame: From Visit 3 (Month 3) up to End of Study (Month 33)
From Visit 3 (Month 3) up to End of Study (Month 33)
Time from NA cessation to the first occurrence of NA retreatment- NA controlled participants with partial response
Time Frame: From Visit 3 (Month 3) up to End of Study (Month 33)
From Visit 3 (Month 3) up to End of Study (Month 33)
Percentage of participants with anti-HBs (antibody to HBsAg)
Time Frame: Up to 33 months
Up to 33 months
Percentage of participants with anti-HBe (antibody to HBeAg)
Time Frame: Up to 33 months
Up to 33 months
Absolute values for HbsAg, hepatitis B virus (HBV) DNA, hepatitis B e-antigen (HbeAg) (logarithm to the base 10 [log10] International units per milliliter [IU/mL])
Time Frame: Up to 33 months
Up to 33 months
Change from Baseline for HbsAg, HBV DNA, HbeAg (log10 IU/mL)
Time Frame: Baseline and up to 33 months
Baseline and up to 33 months
Absolute values for hepatitis B core related antigen (HbcrAg) (kiloUnits per milliliter [kU/mL])
Time Frame: Up to 33 months
Up to 33 months
Change from Baseline for HbcrAg (kU/mL)
Time Frame: Baseline and up to 33 months
Baseline and up to 33 months
Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)
Time Frame: Up to 33 months
Up to 33 months
Change from Baseline for HBV RNA (log10 IU/ml)
Time Frame: Baseline and up to 33 months
Baseline and up to 33 months
Percentage of participants with mutations
Time Frame: Up to 33 months
Up to 33 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)

November 25, 2021

Primary Completion (Estimated)

October 11, 2029

Study Completion (Estimated)

October 11, 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)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206882

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

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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