Trial · NCT05612581
A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
NCT05612581, Phase 1, Phase 2, Completed, Vir Biotechnology, Inc.; results first posted 2025-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection. Trials, record NCT05612581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05612581
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
- NCT number
- NCT05612581
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Vir Biotechnology, Inc.
- Conditions
- Hepatitis B, Chronic
- Interventions
- VIR-3434, VIR-2218, TDF, PEG-IFNα
- First posted
- 2022-11-10
- Last updated
- 2026-02-09
- Results first posted
- 2025-11-26
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment | Up to 48 weeks | |
| Secondary | STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 96 weeks | |
| Secondary | STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment | Up to 48 weeks | |
| Secondary | STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment | Up to 72 weeks | |
| Secondary | STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study | Up to 96 weeks | |
| Secondary | STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study | Up to 96 weeks | |
| Secondary | STRIVE and THRIVE: Time to Achieve Nadir of Serum HBsAg During the Study | Up to 96 weeks | |
| Secondary | STRIVE and THRIVE: Time to Achieve Serum HBsAg Loss (< 0.05 IU/mL) | Up to 96 weeks | |
| Secondary | STRIVE and THRIVE: Proportion of Participants With HBsAg Loss With Anti-HBs Seroconversion at End of Treatment and at 24 Weeks Post-end of Treatment | Up to 76 weeks | |
| Secondary | STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit | Up to 96 weeks |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment | Up to 48 weeks | Cohort 1a, 2a, 3a,5a and 1b was not opened for enrollment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 96 weeks | |||
| SECONDARY | STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment | Up to 48 weeks | |||
| SECONDARY | STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment | Up to 72 weeks | |||
| SECONDARY | STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study | Up to 96 weeks | |||
| SECONDARY | STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study | Up to 96 weeks | |||
| SECONDARY | STRIVE and THRIVE: Time to Achieve Nadir of Serum HBsAg During the Study | Up to 96 weeks | |||
| SECONDARY | STRIVE and THRIVE: Time to Achieve Serum HBsAg Loss (< 0.05 IU/mL) | Up to 96 weeks | |||
| SECONDARY | STRIVE and THRIVE: Proportion of Participants With HBsAg Loss With Anti-HBs Seroconversion at End of Treatment and at 24 Weeks Post-end of Treatment | Up to 76 weeks | |||
| SECONDARY | STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit | Up to 96 weeks |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment | STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | 1 | Participants | ||
| STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment | THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | 4 | Participants |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | STRIVE: Cohort 1a (VIR-3434 + TDF) | 0 | |
| Overall Study | STARTED | STRIVE: Cohort 2a (VIR-3434 + TDF) | 0 | |
| Overall Study | STARTED | STRIVE: Cohort 3a (VIR-3434 + TDF) | 0 | |
| Overall Study | STARTED | STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | 16 | |
| Overall Study | STARTED | STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) | 0 | |
| Overall Study | STARTED | THRIVE: Cohort 1b (VIR-3434 + TDF) | 0 | |
| Overall Study | STARTED | THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | 17 | |
| Overall Study | COMPLETED | STRIVE: Cohort 1a (VIR-3434 + TDF) | 0 | |
| Overall Study | COMPLETED | STRIVE: Cohort 2a (VIR-3434 + TDF) | 0 | |
| Overall Study | COMPLETED | STRIVE: Cohort 3a (VIR-3434 + TDF) | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events322
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Influenza like illness | General disorders | STRIVE: Cohort 1a (VIR-3434 + TDF) | 0 | 0 | 0 |
| other | Influenza like illness | General disorders | STRIVE: Cohort 2a (VIR-3434 + TDF) | 0 | 0 | 0 |
| other | Influenza like illness | General disorders | STRIVE: Cohort 3a (VIR-3434 + TDF) | 0 | 0 | 0 |
| other | Influenza like illness | General disorders | STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | 0 | 16 | |
| other | Influenza like illness | General disorders | STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) | 0 | ||
| other | Influenza like illness | General disorders | THRIVE: Cohort 1b (VIR-3434 + TDF) | 0 | ||
| other | Influenza like illness | General disorders | THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | 4 | 17 | |
| other | Chills | General disorders | STRIVE: Cohort 1a (VIR-3434 + TDF) | 0 | ||
| other | Chills | General disorders | STRIVE: Cohort 2a (VIR-3434 + TDF) | 0 | ||
| other | Chills | General disorders | STRIVE: Cohort 3a (VIR-3434 + TDF) | 0 |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | STRIVE: Cohort 1a (VIR-3434 + TDF) | 0 | 0 |
| Total, all-cause mortality | STRIVE: Cohort 2a (VIR-3434 + TDF) | 0 | 0 |
| Total, all-cause mortality | STRIVE: Cohort 3a (VIR-3434 + TDF) | 0 | 0 |
| Total, all-cause mortality | STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | 0 | 0 |
| Total, all-cause mortality | STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) | 0 | 16 |
| Total, all-cause mortality | THRIVE: Cohort 1b (VIR-3434 + TDF) | 0 | 0 |
| Total, all-cause mortality | THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | 0 | 17 |
| Total, other adverse events | STRIVE: Cohort 1a (VIR-3434 + TDF) | 0 | 0 |
| Total, other adverse events | STRIVE: Cohort 2a (VIR-3434 + TDF) | 0 | 0 |
| Total, other adverse events | STRIVE: Cohort 3a (VIR-3434 + TDF) | 0 | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
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/NCT05612581
GET https://conductscience.org/api/trials/v1/NCT05612581/registered?page=2