2022-501901-10-00招募中4 期
A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 53
- 主要终点
- Exposure-adjusted incidence of participants with liverrelated events: hepatic decompensation (ie, ascites, jaundice, hepatic encephalopathy, portal hypertensionrelated gastro-intestinal bleeding [GIB]), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death through 144 weeks of BLV treatment
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Exposure-adjusted incidence of participants with liverrelated events: hepatic decompensation (ie, ascites, jaundice, hepatic encephalopathy, portal hypertensionrelated gastro-intestinal bleeding [GIB]), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death through 144 weeks of BLV treatment
Exposure-adjusted incidence of participants with liverrelated events: hepatic decompensation (ie, ascites, jaundice, hepatic encephalopathy, portal hypertensionrelated gastro-intestinal bleeding [GIB]), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death through 144 weeks of BLV treatment
次要结局
- Percentage of participants who develop cirrhosis during the study among participants who were previously noncirrhotic Percentage of participants with serious adverse events (SAEs), Grade 3 or 4 adverse events (AEs), and discontinuations due to AEs
研究者
EU Clinical Trials Support
Scientific
Gilead Sciences Inc.
研究点 (53)
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