Study of Bulevirtide in Participants With Chronic Hepatitis D Infection (NCT05718700) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Study of Bulevirtide in Participants With Chronic Hepatitis D Infection
Austria, France170 participantsStarted 2023-02-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Individuals who have been diagnosed with chronic hepatitis D virus (HDV) infection for at least 6 months before study enrollment, confirmed by respective documentation in the individuals' medical records.
* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
* Must be willing and able to comply with the visit schedule and study requirements.
* Cohort 1 only: Must have participated in study MYR-Reg-02.
* Cohort 2 only: Individuals scheduled to receive bulevirtide (BLV) according to the approved label or for whom the decision to start treatment with BLV according to the approved label has been made and treatment initiation is planned.
Key Exclusion Criteria:
* Individuals currently enrolled in BLV clinical treatment studies and/or other interventional clinical studies with an investigational agent.
* History or current presence of clinically significant illness or any other major medical disorder that may interfere with individual follow-up, assessments, or compliance with the protocol.
* Coinfection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) (Individuals with HCV antibodies can be enrolled if HCV RNA is negative).
* Solid organ transplantation.
* Any history, or current evidence of clinical hepatic decompensation (ie, ascites, encephalopathy, jaundice, or gastrointestinal bleeding (GIB)).
* Presence of hepatocellular carcinoma (HCC) as ā¦
What they're measuring
1
Exposure-adjusted Incidence of Participants With Liver-related Event: Hepatic Decompensation, Hepatocellular Carcinoma (HCC), Liver Transplantation, and Liver-related Death