Trial · NCT07908459
B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants
NCT07908459, Phase 4, Not yet recruiting, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants. Trials, record NCT07908459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07908459
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants
- NCT number
- NCT07908459
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 303 participants, estimated
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hepatitis B
- Interventions
- Bepirovirsen
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From B-Well Week 72 to Confirmed Loss of Response | From B-Well Week 72 assessment up to Month 48 | Confirmed loss of response is defined as HBsAg greater than (\>)100 IU/mL at two consecutive assessments. |
| Secondary | Absolute HBsAg Value at Each Follow-up Assessment | From B-Well Week 72 assessment up to Month 48 | |
| Secondary | Change From Week 72 in HBsAg Level at Each Follow-up Assessment | From B-Well Week 72 assessment up to Month 48 | |
| Secondary | Proportion of Participants Maintaining or Achieving Predefined HBsAg Thresholds | From B-Well Week 72 assessment up to Month 48 | Thresholds of interest include HBsAg \<= 100 IU/mL, HBsAg \<= 10 IU/mL, or HBsAg Loss. HBsAg loss is defined as HBsAg less than (\<) lower limit of quantification (LLOQ) at 2 sequential visits. |
| Secondary | Proportion of Participants Who Achieve Functional Cure | From B-Well Week 72 assessment up to Month 48 | Functional cure is defined as sustained suppression (24 weeks or longer) of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) (\<LLOQ) off all HBV treatment and loss of HBsAg (HBsAg \< LLOQ at 2 sequential visits) with or without hepatitis B surface antibody (HBsAb) after a finite duration of therapy. |
| Secondary | Number of Participants with Clinical Relapse | From B-Well Week 72 assessment up to Month 48 | Clinical relapse is defined as HBsAg \>= Lower limit of Quantification (LLOQ) and HBV Deoxyribonucleic Acid (DNA) \>2000 IU/mL and Alanine Aminotransferase (ALT) \>2x Upper Limit of Normal (ULN) at 2 sequential visits. |
| Secondary | Change From Week 72 Baseline in Hepatitis B Quality of Life Questionnaire (HBQoL) Score | From B-Well Week 72 assessment up to Month 48 | HBQoL has been designed to assess quality of life in participants with hepatitis B. It consists of 31 items and 6 domains: psychological well-being, anticipation anxiety, vitality, stigma, transmissibility and vulnerability. Response options range from 1 to 5 with higher scores indicating more severe impact of hepatitis B. |
| Secondary | Number of Participants with Healthcare Resource Utilization (HCRU) | From B-Well Week 72 assessment up to Month 48 | HCRU includes hospitalizations, emergency department visits, outpatient visits, specialist consultations, and liver-related interventions |
| Secondary | Number of Participants with Hepatic Disease Progression Outcomes | From B-Well Week 72 assessment up to Month 48 | Hepatic disease progression outcomes will include cirrhosis, hepatic decompensation, HCC, liver transplantation, liver-related mortality, all-cause mortality. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07908459
GET https://conductscience.org/api/trials/v1/NCT07908459/registered