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Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

StatusTerminated
PhaseNot specified
Started2023-02-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-19
critical
Trial terminated: Sponsor decision, no safety concerns.
Primary completion confirmed: August 2026 (last estimated July 2028)
2025-11-14
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v30
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2027-11→2028-07
Completion date2027-11→2028-07
Study sitesdetails revised at 53 of 53 sites
2025-03-19
minor
Study Status, Contacts/Locations v29
Study sitesdetails revised at 3 of 53 sites
2025-02-20
minor
Study Status, Contacts/Locations v28
Study sitesdetails revised at 1 of 53 sites
2024-12-18
minor
Study Status, Contacts/Locations v27
Study sitesdetails revised at 1 of 53 sites
Show 26 earlier versions
2024-12-05
minor
Study Status, Contacts/Locations v26
Study sites51→53
2024-11-07
minor
Study Status, Contacts/Locations v25
Study sites50→51
2024-10-11
minor
Study Status, Contacts/Locations v24
Study sitesdetails revised at 11 of 50 sites
2024-09-05
minor
Study Status, Contacts/Locations v23
Study sites51→50
2024-08-13
minor
Study Status v22
Re-verified, no change to tracked fields
2024-07-15
minor
Study Status, Contacts/Locations v21
Study sites50→51
2024-06-20
minor
Study Status, Contacts/Locations v20
Study sites46→50
2024-05-30
minor
Study Status, Contacts/Locations v19
Study sites45→46
2024-05-03
minor
Study Status, Contacts/Locations v18
Study sites42→45
2024-04-12
minor
Study Status v17
Re-verified, no change to tracked fields
2024-03-19
minor
Study Status, Contacts/Locations v16
Study sites40→42
2024-02-26
minor
Study Status, Contacts/Locations v15
Study sites38→40
2024-02-02
minor
Study Status, Contacts/Locations v14
Study sites36→38
2024-01-08
minor
Study Status, Contacts/Locations v13
Study sites32→36
2023-12-15
minor
Study Status, Contacts/Locations v12
Study sites31→32
2023-12-05
minor
Study Status, Contacts/Locations v11
Study sites18→31
2023-11-06
minor
Study Identification, Study Status, Contacts/Locations v10
Study sites13→18
2023-10-03
minor
Study Status, Contacts/Locations v9
Study sites5→13
2023-09-14
minor
2 amendments v7-v8
2 re-verifications since 2023-08-07, no change to tracked fields
2023-07-12
minor
Study Status, Contacts/Locations v6
Study sites3→5
2023-06-21
minor
Study Status v5
Re-verified, no change to tracked fields
2023-05-15
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 2 of 3 sites
2023-04-18
minor
Study Status v3
Re-verified, no change to tracked fields
2023-03-30
minor
Study Status, Arms and Interventions, Contacts/Locations v2
Study sites1→3
InterventionsBulevirtide (Biological)→Bulevirtide (Drug)
2023-03-01
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-02→confirmed 2023-02-07
Study sites0→1
2023-01-30
minor
Original filing
107 trials monitored
See 8 trials at risk
The main goal of this study is to collect post marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide.
Trial Details
NCT Number NCT05718700
Lead Sponsor Gilead Sciences
Conditions Chronic Hepatitis D Infection
Enrollment 170 participants
Start Date 2023-02-07
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-18