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

NCT04954859 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2068822023-506867-33
• Study Type: interventional
• Target: 450
• Locations: 18 countries
• Sites: 51

Brief Summary

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.

Conditions

Hepatitis B

Keywords

Bepirovirsen; B-Sure; Nucleos(t)ide; Durability; HBsAg; Functional cure

Outcome Measures

Primary Outcomes (4)

• Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO)

  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

  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

  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

  From primary endpoint assessment in the parent study up to Month 33

Secondary Outcomes (24)

• 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)

  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)

  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)

  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)

  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

  From primary endpoint assessment in the parent study up to Month 33

Study Arms (3)

Not-on-NA participants

EXPERIMENTAL

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; Drug: Placebo

On-NA participants

EXPERIMENTAL

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; Drug: Placebo

NA-cessated participants

EXPERIMENTAL

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; Drug: Placebo

Interventions

Bepirovirsen DRUG

No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.

NA-cessated participants; Not-on-NA participants; On-NA participants

Placebo DRUG

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.

NA-cessated participants; Not-on-NA participants; On-NA participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (51)

GSK Investigational Site

Sacramento, California, 95817, United States

RECRUITING

GSK Investigational Site

Boston, Massachusetts, 02114, United States

RECRUITING

GSK Investigational Site

Detroit, Michigan, 48202, United States

RECRUITING

GSK Investigational Site

Buenos Aires, C1181ACH, Argentina

RECRUITING

GSK Investigational Site

Sliven, 8800, Bulgaria

RECRUITING

GSK Investigational Site

Sofia, 1431, Bulgaria

RECRUITING

GSK Investigational Site

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

GSK Investigational Site

Victoria, British Columbia, V8R 6R3, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

GSK Investigational Site

Hangzhou, 310000, China

RECRUITING

GSK Investigational Site

Shanghai, 200025, China

RECRUITING

GSK Investigational Site

Wuhan, 430030, China

RECRUITING

GSK Investigational Site

Clichy, 92110, France

RECRUITING

GSK Investigational Site

Strasbourg, 67200, France

RECRUITING

GSK Investigational Site

Pokfulam, Hong Kong

RECRUITING

GSK Investigational Site

Milan, 20122, Italy

RECRUITING

GSK Investigational Site

Milan, 20157, Italy

RECRUITING

GSK Investigational Site

Modena, 40126, Italy

RECRUITING

GSK Investigational Site

Hiroshima, 730-8619, Japan

RECRUITING

GSK Investigational Site

Hiroshima, 734-8551, Japan

RECRUITING

GSK Investigational Site

Ishikawa, 920-8650, Japan

RECRUITING

GSK Investigational Site

Kagawa, 760-8557, Japan

RECRUITING

GSK Investigational Site

Kumamoto, 862-8655, Japan

RECRUITING

GSK Investigational Site

Miyagi, 980-8574, Japan

RECRUITING

GSK Investigational Site

Osaka, 565-0871, Japan

RECRUITING

GSK Investigational Site

Tokyo, 113-8603, Japan

RECRUITING

GSK Investigational Site

Tokyo, 180-8610, Japan

RECRUITING

GSK Investigational Site

Lublin, 20081, Poland

RECRUITING

GSK Investigational Site

Craiova Dolj, 417307, Romania

RECRUITING

GSK Investigational Site

Galati, 800179, Romania

RECRUITING

GSK Investigational Site

Chelyabinsk, 454052, Russia

RECRUITING

GSK Investigational Site

Moscow, 121170, Russia

RECRUITING

GSK Investigational Site

Novosibirsk, 630099, Russia

RECRUITING

GSK Investigational Site

Saint Petersburg, 190103, Russia

RECRUITING

GSK Investigational Site

Saint Petersburg, 191167, Russia

RECRUITING

GSK Investigational Site

Samara, 443063, Russia

RECRUITING

GSK Investigational Site

Красноярск, 660049, Russia

RECRUITING

GSK Investigational Site

Singapore, 119074, Singapore

RECRUITING

GSK Investigational Site

Singapore, 529889, Singapore

RECRUITING

GSK Investigational Site

Durban, 4091, South Africa

RECRUITING

GSK Investigational Site

Johannesburg, 1830, South Africa

RECRUITING

GSK Investigational Site

Ansan-si Gyenggi-do, 15355, South Korea

RECRUITING

GSK Investigational Site

Busan, 47392, South Korea

RECRUITING

GSK Investigational Site

Pusan, 49241, South Korea

RECRUITING

GSK Investigational Site

Seoul, 05505, South Korea

RECRUITING

GSK Investigational Site

Madrid, 28031, Spain

RECRUITING

GSK Investigational Site

Santander, 39008, Spain

RECRUITING

GSK Investigational Site

Bangkok, 10400, Thailand

RECRUITING

GSK Investigational Site

Kho Hong Hat Yai, 90110, Thailand

RECRUITING

GSK Investigational Site

London, WC1E 6JB, United Kingdom

RECRUITING

GSK Investigational Site

Plymouth, PL68DH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: December 14, 2021
• Primary Completion (Estimated): February 8, 2029
• Study Completion (Estimated): February 8, 2029
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

CN (3); AR (1); FR (2); RU (7); ES (2); RO (2); HK (1); JP (9); IT (3); GB (2); US (3); BU (2); PL (1); TH (2); ZA (2); CA (3); KR (4); SG (2)