A Registry Study Bulevirtide in Participants With Chronic Hepatitis D
Research type
Research Study
Full title
A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection.
IRAS ID
1009095
Contact name
Stanislava Hristova
Contact email
Sponsor organisation
Gilead Sciences Inc.
Eudract number
2021-004011-29
Clinicaltrials.gov Identifier
Research summary
The purpose of this clinical research study is to collect post marketing data from participants with chronic hepatitis D virus (HDV) infection who are treated with Bulevirtide (BLV) under the brand name Hepcludex to evaluate the safety and long-term effects of BLV treatment.
This study will enrol about 170 participants in about 75 locations worldwide, who participated in study MYR-Reg-02 or are scheduled to receive BLV as prescribed by their healthcare provider according to the approved label. Participants will not be provided BLV in this research study; they will be receiving or be scheduled to receive BLV, as prescribed by their healthcare provider according to the approved label.
Participants total time in the study will be 144 weeks/approx. 33 months and 7 visits to the study clinic are required.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
24/NE/0046
Date of REC Opinion
20 May 2024
REC opinion
Further Information Favourable Opinion