Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03852719 | Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD) | PHASE3 | COMPLETED | 150 | — | — | Apr 17, 2019 | Aug 8, 2024 | Aug 22, 2025 | 19 | United States, Germany +3 |
| NCT03852433 | Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD) | PHASE2 | COMPLETED | 175 | — | — | May 31, 2019 | Sep 28, 2022 | Oct 8, 2024 | 20 | France, Moldova +2 |
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.
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).
| Arm | Type | Description |
|---|---|---|
| Delayed Treatment/Bulevirtide 10 mg/day | EXPERIMENTAL | After an observational period of 48 weeks, participants will receive treatment with bulevirtide 10 mg/day subcutaneously (SC) for 96 weeks and will be followed for up to 96 weeks (Up to Week 240). |
| Bulevirtide 2 mg/day | EXPERIMENTAL | Participants will receive bulevirtide 2 mg/day SC for 144 weeks and will be followed for up to 96 weeks (Up to Week 240). |
| Bulevirtide 10 mg/day | EXPERIMENTAL | Participants will receive bulevirtide 10 mg/day SC for 144 weeks and will be followed for up to 96 weeks (Up to Week 240). |
| Pegylated Interferon alfa-2a (PEG-IFN alfa) | ACTIVE_COMPARATOR | Participants will receive PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up. |
| Bulevirtide 2 mg/day + PEG-IFN alfa | EXPERIMENTAL | Participants will receive bulevirtide 2 mg once a day subcutaneously incombination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up. |
| Bulevirtide 10 mg/day + PEG-IFN alfa | EXPERIMENTAL | Participants will receive bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up. |
| Bulevirtide 10 mg once a day | EXPERIMENTAL | Participants will receive bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up |
| Name | Type | Description |
|---|---|---|
| Bulevirtide | DRUG | Administered via SC injections |
| Peginterferon Alfa-2a (PEG-IFN alfa) | DRUG | Administered via subcutaneous injections |
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Positive serum anti-hepatitis delta virus (HDV) antibody results or polymerase chain reaction (PCR) results for serum/ plasma HDV ribonucleic acid (RNA) for at least 6 months before screening. 3. Positive PCR results for...