A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection - GS-US-589-6206

Gilead Sciences Inc.0 个研究点目标入组 220 人开始时间: 2022年9月20日最近更新: 2024年8月21日

适应症

试验速览

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•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

•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.

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