Trial · NCT03852719
Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)
NCT03852719, Phase 3, Completed, Gilead Sciences; results first posted 2022-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD). Trials, record NCT03852719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03852719
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)
- NCT number
- NCT03852719
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Chronic Hepatitis Delta
- Interventions
- Bulevirtide
- First posted
- 2019-02-25
- Last updated
- 2025-08-22
- Other registries' IDs
- eudract:2019-001213-17
- Results first posted
- 2022-10-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Combined Response at Week 48 | Week 48 | Combined response was defined as fulfilment of two conditions simultaneously: Undetectable (\< lower limit of quantification (LLOQ, target not detected)) HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline; and ALT normalization. |
| Secondary | Percentage of Participants With Undetectable HDV RNA at Week 48 | Week 48 | Undetectable HDV RNA at Week 48 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 48. |
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | Week 48 | ALT normalization was defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]) |
| Secondary | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 48 | ANCOVA was used for analysis. |
| Secondary | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 96 | Mixed model for repeated measurements (MMRM) was used for analysis. |
| Secondary | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144 | Baseline, Week 144 | MMRM was used for analysis. |
| Secondary | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 192 | MMRM was used for analysis. |
| Secondary | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 240 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 240 | MMRM was used for analysis. |
| Secondary | Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response) | Week 168 | Undetectable HDV RNA 24 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 168 |
| Secondary | Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response) | Week 192 | Undetectable HDV RNA 48 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 192 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Combined Response at Week 48 | Week 48 | The Full Analysis Set included participants randomized to delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Undetectable HDV RNA at Week 48 | Week 48 | Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | Week 48 | Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 48 | Participants in the Full Analysis Set with available data were analyzed. Data is reported separately for changes from Baseline at Week 48 for the Delayed Treatment arm and for Delayed Treatment/Bulevirtide 10 mg/day arm after 48 weeks of bulevirtide 10 mg treatment. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly. | kPa | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 96 | Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly. | kPa | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144 | Baseline, Week 144 | Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly. | kPa | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 192 | Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly. | kPa | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 240 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 240 | Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly. | kPa | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response) | Week 168 | Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response) | Week 192 | Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Combined Response at Week 48 | Delayed Treatment | 2.0 | 95% Confidence Interval 0.0 to 10.4 | percentage of participants | |
| Percentage of Participants With Combined Response at Week 48 | Bulevirtide 2 mg/Day | 44.9 | 95% Confidence Interval 30.7 to 59.8 | percentage of participants | |
| Percentage of Participants With Combined Response at Week 48 | Bulevirtide 10 mg/Day | 48.0 | 95% Confidence Interval 33.7 to 62.6 | percentage of participants | |
| Percentage of Participants With Undetectable HDV RNA at Week 48 | Delayed Treatment | 0 | 95% Confidence Interval 0.0 to 7.0 | percentage of participants | |
| Percentage of Participants With Undetectable HDV RNA at Week 48 | Bulevirtide 2 mg/Day | 12.2 | 95% Confidence Interval 4.6 to 24.8 | percentage of participants | |
| Percentage of Participants With Undetectable HDV RNA at Week 48 | Bulevirtide 10 mg/Day | 20.0 | 95% Confidence Interval 10.0 to 33.7 | percentage of participants | |
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | Delayed Treatment | 11.8 | 95% Confidence Interval 4.4 to 23.9 | percentage of participants | |
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | Bulevirtide 2 mg/Day | 51.0 | 95% Confidence Interval 36.3 to 65.6 | percentage of participants | |
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | Bulevirtide 10 mg/Day | 56.0 | 95% Confidence Interval 41.3 to 70.0 | percentage of participants | |
| Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48 | Delayed Treatment | 0.87 | 95% Confidence Interval -0.79 to 2.53 | kPa |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Delayed Treatment/Bulevirtide 10 mg/Day | 51 | |
| Overall Study | STARTED | Bulevirtide 2 mg/Day | 49 | |
| Overall Study | STARTED | Bulevirtide 10 mg/Day | 50 | |
| Overall Study | Did Not Receive Bulevirtide | Delayed Treatment/Bulevirtide 10 mg/Day | 1 | |
| Overall Study | Did Not Receive Bulevirtide | Bulevirtide 2 mg/Day | 0 | |
| Overall Study | Did Not Receive Bulevirtide | Bulevirtide 10 mg/Day | 0 | |
| Overall Study | COMPLETED | Delayed Treatment/Bulevirtide 10 mg/Day | 28 | |
| Overall Study | COMPLETED | Bulevirtide 2 mg/Day | 28 | |
| Overall Study | COMPLETED | Bulevirtide 10 mg/Day | 30 | |
| Overall Study | NOT COMPLETED | Delayed Treatment/Bulevirtide 10 mg/Day | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events720
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 | Anaemia | Blood and lymphatic system disorders | Delayed Treatment (Baseline to Week 48) | 3 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Bulevirtide 2 mg/Day (Baseline to Week 48) | 3 | 49 | |
| other | Anaemia | Blood and lymphatic system disorders | Bulevirtide 10 mg/Day (Baseline to Week 48) | 2 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Bulevirtide 2 mg/Day (Baseline to Week 144) | 5 | 49 | |
| other | Anaemia | Blood and lymphatic system disorders | Bulevirtide 10 mg/Day (Baseline to Week 144) | 3 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Delayed Treatment/Bulevirtide 10 mg/Day (Week 48 to Week 144) | 3 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Bulevirtide 2 mg/Day (After EOT (>Week 144 up to Week 240)) | 1 | 46 | |
| other | Anaemia | Blood and lymphatic system disorders | Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240) | 1 | 47 | |
| other | Anaemia | Blood and lymphatic system disorders | Delayed Treatment/Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240) | 5 | 49 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Delayed Treatment (Baseline to Week 48) | 0 | 51 |
1 to 10 of 720Source ClinicalTrials.gov
See all 720 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Delayed Treatment (Baseline to Week 48) | 0 | 51 |
| Total, all-cause mortality | Bulevirtide 2 mg/Day (Baseline to Week 48) | 0 | 49 |
| Total, all-cause mortality | Bulevirtide 10 mg/Day (Baseline to Week 48) | 0 | 50 |
| Total, all-cause mortality | Bulevirtide 2 mg/Day (Baseline to Week 144) | 0 | 49 |
| Total, all-cause mortality | Bulevirtide 10 mg/Day (Baseline to Week 144) | 0 | 50 |
| Total, all-cause mortality | Delayed Treatment/Bulevirtide 10 mg/Day (Week 48 to Week 144) | 1 | 50 |
| Total, all-cause mortality | Bulevirtide 2 mg/Day (After EOT (>Week 144 up to Week 240)) | 0 | 46 |
| Total, all-cause mortality | Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240) | 0 | 47 |
| Total, all-cause mortality | Delayed Treatment/Bulevirtide 10 mg/Day (After EOT (>Week 144 up to Week 240) | 0 | 49 |
| Total, other adverse events | Delayed Treatment (Baseline to Week 48) | 30 | 51 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
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/NCT03852719
GET https://conductscience.org/api/trials/v1/NCT03852719/results?page=2