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

NCT04954859
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
360
clinicaltrials.gov
Lead sponsor
GlaxoSmithKline
clinicaltrials.gov
Start date
2021-12-14
clinicaltrials.gov
Number of sites
163
clinicaltrials.gov

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.
clinicaltrials.gov
Acronym
B-Sure
clinicaltrials.gov
Short title
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
clinicaltrials.gov
Official title
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
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2029-01-24
clinicaltrials.gov
First posted
2021-07-08
clinicaltrials.gov
Registry last updated
2026-06-24
clinicaltrials.gov
Primary completion date
2029-01-24
clinicaltrials.gov
Start date
2021-12-14
clinicaltrials.gov

Participants
360
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
360
clinicaltrials.gov
Protocol amendments
2
clinicaltrials.gov
Number of sites
163
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
GlaxoSmithKline
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT04954859
clinicaltrials.gov
ClinicalTrials.gov ID
NCT04954859
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: From primary endpoint assessment in the parent study up to Month 57

    NA indicates nucleos(t)ide analogue (NA).

  2. Percentage of On-NA participants rolling over from studies 209668 and 209348 without loss of functional cure (FC) after NA-cessation in study 206882

    Timeframe: From Month 3 up to Month 57

  3. Percentage of On-NA participants rolling over from study 217023 without loss of FC after NA-cessation in study 206882

    Timeframe: From Month 3 up to Month 33

  4. Percentage of NA-cessated participants rolling over from studies 202009 and 219288 without loss of FC after NA-cessation in the parent study

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

  1. 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)

    Timeframe: Up to Month 57

  2. 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)

    Timeframe: Up to Month 57

  3. 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)

    Timeframe: Up to Month 57

  4. 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)

    Timeframe: Up to Month 57

  5. 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

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

  6. 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

    Timeframe: Up to Month 57

  7. 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

    Timeframe: From date of achieving delayed FC up to Month 57

  8. 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

    Timeframe: Up to Month 57

  9. 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

    Timeframe: From date of achieving delayed FC up to Month 57

  10. 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

    Timeframe: Up to Month 33

  11. 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

    Timeframe: From date of achieving delayed treatment response up to Month 33

  12. 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

    Timeframe: From Month 3 to Month 57

  13. 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

    Timeframe: From Month 3 up to Month 57

  14. 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

    Timeframe: From Month 3 up to Month 57

  15. 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

    Timeframe: From Month 3 up to Month 57

  16. Percentage of participants with anti-HBs (antibody to HBsAg)

    Timeframe: Up to 57 months

  17. Percentage of participants with anti-HBe (antibody to hepatitis B e-antigen [HBeAg])

    Timeframe: Up to 57 months

  18. Absolute values for HBsAg, hepatitis B virus (HBV) deoxyribonucleic acid (DNA), HBeAg (logarithm to the base 10 [log10] international units per milliliter [IU/mL])

    Timeframe: Up to 57 months

  19. Change from Baseline for HBsAg, HBV DNA, HBeAg (log10 IU/mL)

    Timeframe: Baseline (End of Study visit in the parent study) and up to 57 months

  20. Absolute values for hepatitis B core-related antigen (HBcrAg) (kiloUnits per milliliter [kU/mL])

    Timeframe: Up to 57 months

  21. Change from Baseline for HBcrAg (kU/mL)

    Timeframe: Baseline (End of Study visit in the parent study) and up to 57 months

  22. Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)

    Timeframe: Up to 57 months

  23. Change from Baseline for HBV RNA (log10 IU/ml)

    Timeframe: Baseline (End of Study visit in the parent study) and up to 57 months

  24. Percentage of participants with mutations

    Timeframe: Up to 57 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • GSK Investigational SiteSacramento, United States
  • GSK Investigational SiteSan Jose, United States
  • GSK Investigational SiteColorado Springs, United States
  • GSK Investigational SiteBoston, United States
  • GSK Investigational SiteDetroit, United States
  • GSK Investigational SiteLa Plata, Argentina
  • GSK Investigational SiteBuenos Aires, Argentina
  • GSK Investigational SiteBuenos Aires, Argentina
  • GSK Investigational SiteRosario, Argentina
  • GSK Investigational SiteSanta Fe, Argentina
  • GSK Investigational SiteHerston, Australia
  • GSK Investigational SiteFitzroy, Australia
  • GSK Investigational SiteAracaju, Brazil
  • GSK Investigational SiteCampinas, Brazil
  • GSK Investigational SiteCuritiba, Brazil
  • GSK Investigational SiteManaus, Brazil
  • GSK Investigational SiteSão Paulo, Brazil
  • GSK Investigational SiteVila Mariana, Brazil
  • GSK Investigational SitePlovdiv, Bulgaria
  • GSK Investigational SiteSliven, Bulgaria
  • GSK Investigational SiteSofia, Bulgaria
  • GSK Investigational SiteSofia, Bulgaria
  • GSK Investigational SiteSofia, Bulgaria
  • GSK Investigational SiteVarna, Bulgaria
  • GSK Investigational SiteCalgary, Canada

And 138 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-506867-33
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)