Trial · NCT03852433
Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)
NCT03852433, Phase 2, Completed, Gilead Sciences; results first posted 2024-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD). Trials, record NCT03852433. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03852433
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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 Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)
- NCT number
- NCT03852433
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 175 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Chronic Hepatitis Delta
- Interventions
- Bulevirtide, Peginterferon Alfa-2a (PEG-IFN alfa)
- First posted
- 2019-02-25
- Last updated
- 2024-10-08
- Other registries' IDs
- eudract:2019-001485-15
- Results first posted
- 2024-07-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24) | 24 weeks after EOT (Week 72 for Arm A and study Week 120 for Arms B, C, and D) | SVR24 was defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \< lower limit of quantitation \[LLOQ\] with target not detected) at 24 weeks after the scheduled end of treatment (EOT). |
| 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 Undetectable HDV RNA at Week 96 (Arms B, C, and D Only) | Week 96 | Undetectable HDV RNA at Week 96 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 96. |
| Secondary | Percentage of Participants With Combined Response at Week 24 After the Scheduled End of Treatment | 24 weeks after EOT (Week 72 for Arm A and Week 120 for Arms B, C, and D) | Combined response was defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, alanine aminotransferase (ALT) normalization, 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 | Percentage of Participants With Combined Response at Week 48 After the Scheduled End of Treatment | 48 weeks after EOT (Week 96 for Arm A and Week 144 for Arm B, C, and D) | Combined response is defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, ALT normalization, 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 | Percentage of Participants With Sustained Virological Response 48 After the Scheduled End of Treatment (SVR 48) | 48 weeks after EOT (Week 96 for Arm A; Week 144 for Arms B, C, and D) | SVR 48 is defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \< lower limit of quantitation \[LLOQ\] with target not detected) at 48 weeks after the scheduled end of treatment. |
| Secondary | Change From Baseline in Liver Stiffness as Measured by Elastography at Week 48 | Baseline, Week 48 | The mixed-effects models for repeated measurements (MMRM) model was used for analysis. |
| Secondary | Change From Baseline in Liver Stiffness as Measured by Elastography at Week 96 | Baseline, Week 96 | The MMRM model was used for analysis. |
| Secondary | Change From Baseline in Liver Stiffness as Measured by Elastography at Week 144 | Baseline, 48 weeks after EOT (Week 96 for Arm A and study Week 144 for Arms B, C, and D) | The MMRM model was used for analysis. |
Source ClinicalTrials.gov
Outcomes9
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 Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24) | 24 weeks after EOT (Week 72 for Arm A and study Week 120 for Arms B, C, and D) | Full Analysis Set, is defined as all randomized participants who received at least 1 dose of study drug (Peg-IFNα and/or BLV). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Undetectable HDV RNA at Week 48 | Week 48 | Participants from Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Undetectable HDV RNA at Week 96 (Arms B, C, and D Only) | Week 96 | Participants from Full Analysis Set were analyzed. Per prespecified analysis, the data for this outcome measure was collected only for Arms B, C, and D at the scheduled Week 96 visit. Hence the data for Arm A is not reported for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Combined Response at Week 24 After the Scheduled End of Treatment | 24 weeks after EOT (Week 72 for Arm A and Week 120 for Arms B, C, and D) | Participants from Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Combined Response at Week 48 After the Scheduled End of Treatment | 48 weeks after EOT (Week 96 for Arm A and Week 144 for Arm B, C, and D) | Participants from Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Virological Response 48 After the Scheduled End of Treatment (SVR 48) | 48 weeks after EOT (Week 96 for Arm A; Week 144 for Arms B, C, and D) | Participants from Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Liver Stiffness as Measured by Elastography at Week 48 | Baseline, Week 48 | Participants from Full Analysis Set with available data were analyzed. | kPa | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Liver Stiffness as Measured by Elastography at Week 96 | Baseline, Week 96 | Participants from Full Analysis Set with available data were analyzed. Per prespecified analysis, the data for this outcome measure was collected only for Arms B, C, and D at the scheduled Week 96 visit. Hence the data for Arm A is not reported for this outcome measure. | kPa | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Liver Stiffness as Measured by Elastography at Week 144 | Baseline, 48 weeks after EOT (Week 96 for Arm A and study Week 144 for Arms B, C, and D) | Participants from Full Analysis Set were analyzed. | kPa | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group34
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 Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24) | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 16.7 | 95% Confidence Interval 4.7 to 37.4 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 32.0 | 95% Confidence Interval 19.5 to 46.7 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24) | Bulevirtide 10 mg/Day + PEG-IFN Alfa | 46.0 | 95% Confidence Interval 31.8 to 60.7 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24) | Bulevirtide 10 mg/Day | 12.0 | 95% Confidence Interval 4.5 to 24.3 | percentage of participants | |
| Percentage of Participants With Undetectable HDV RNA at Week 48 | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 20.8 | 95% Confidence Interval 7.1 to 42.2 | percentage of participants | |
| Percentage of Participants With Undetectable HDV RNA at Week 48 | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 40.0 | 95% Confidence Interval 26.4 to 54.8 | percentage of participants | |
| Percentage of Participants With Undetectable HDV RNA at Week 48 | Bulevirtide 10 mg/Day + PEG-IFN Alfa | 60.0 | 95% Confidence Interval 45.2 to 73.6 | percentage of participants | |
| Percentage of Participants With Undetectable HDV RNA at Week 48 | Bulevirtide 10 mg/Day | 10.0 | 95% Confidence Interval 3.3 to 21.8 | percentage of participants | |
| Percentage of Participants With Undetectable HDV RNA at Week 96 (Arms B, C, and D Only) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 44.0 | 95% Confidence Interval 30.0 to 58.7 | percentage of participants | |
| Percentage of Participants With Undetectable HDV RNA at Week 96 (Arms B, C, and D Only) | Bulevirtide 10 mg/Day + PEG-IFN Alfa | 70.0 | 95% Confidence Interval 55.4 to 82.1 | percentage of participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 25 | |
| Overall Study | STARTED | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 50 | |
| Overall Study | STARTED | Bulevirtide 10 mg/Day + PEG-IFN Alfa | 50 | |
| Overall Study | STARTED | Bulevirtide 10 mg/Day | 50 | |
| Overall Study | COMPLETED | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 17 | |
| Overall Study | COMPLETED | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 38 | |
| Overall Study | COMPLETED | Bulevirtide 10 mg/Day + PEG-IFN Alfa | 45 | |
| Overall Study | COMPLETED | Bulevirtide 10 mg/Day | 45 | |
| Overall Study | NOT COMPLETED | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 8 | |
| Overall Study | NOT COMPLETED | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events272
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 | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 1 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 4 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Bulevirtide 10 mg/Day + PEG-IFN Alfa | 6 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Bulevirtide 10 mg/Day | 1 | 50 | |
| other | Leukopenia | Blood and lymphatic system disorders | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 13 | 24 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 26 | 50 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bulevirtide 10 mg/Day + PEG-IFN Alfa | 27 | 50 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bulevirtide 10 mg/Day | 8 | 50 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 7 | 24 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 12 | 50 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 0 | 25 |
| Total, all-cause mortality | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 1 | 50 |
| Total, all-cause mortality | Bulevirtide 10 mg/Day + PEG-IFN Alfa | 1 | 50 |
| Total, all-cause mortality | Bulevirtide 10 mg/Day | 0 | 50 |
| Total, other adverse events | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 22 | 24 |
| Total, other adverse events | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 49 | 50 |
| Total, other adverse events | Bulevirtide 10 mg/Day + PEG-IFN Alfa | 50 | 50 |
| Total, other adverse events | Bulevirtide 10 mg/Day | 37 | 50 |
| Total, serious adverse events | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 3 | 24 |
| Total, serious adverse events | Bulevirtide 2 mg/Day + PEG-IFN Alfa | 3 | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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/NCT03852433
GET https://conductscience.org/api/trials/v1/NCT03852433/results?page=2