BridgeMD
A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection
EU CTIS ID: 2022-501901-10-00
What this study is testing
To evaluate the long-term effects of bulevirtide (BLV) treatment on clinical progression of liver disease through the incidence of liver-related events in participants treated with BLV
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Adult (≥ 18 years) participants 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 participants’ medical records. 2) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. 3) Must be willing and able to comply with the visit schedule and study requirements. 4) Cohort 1 only: Must have participated in study MYR-Reg-02 and have the following documented results: a) Assessment of ascites and hepatic encephalopathy within 3 months prior to start of BLV treatment b) Laboratory analytes required to calculate Child-Turcotte-Pugh (CTP) and Model for End-Stage Liver Disease (MELD) scores within 3 months prior to start of BLV treatment as follows: i) Serum bilirubin ii) Serum creatinine iii) International normalized ratio (INR) iv) Serum albumin c) Documentation of fibrosis status assessment within 6 months prior to start of BLV treatment by at least 1 of the following: i) Biopsy ii) FibroScan® d) Quantitative HDV RNA within 3 months prior to start of BLV treatment e) Alanine aminotransferase (ALT) within 3 months prior to start of BLV treatment 5) Cohort 2 only: Participants scheduled to receive 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
You likely can't join if
- 1) Participants currently enrolled in BLV clinical treatment studies and/or other interventional clinical studies with an investigational agent. 2) History or current presence of clinically significant illness or any other major medical disorder that may interfere with participant follow-up, assessments, or compliance with the protocol. 3) Coinfection with hepatitis C virus (HCV) or HIV (Participants with HCV antibodies can be enrolled if HCV RNA is negative) 4) Solid organ transplantation 5) Any history, or current evidence of clinical hepatic decompensation (ie, ascites, encephalopathy, jaundice, or GIB) 6) Presence of HCC as evidenced by imaging (eg, ultrasound or computed tomography scan) performed within 4 months prior to Day 1 for participants with cirrhosis and within 6 months prior to Day 1 for participants without cirrhosis 7) Individuals deemed by the study investigator to be inappropriate for study participation for any reason not otherwise listed.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.