A Prospective, Observational Clinical Study to Evaluate the Incidence of Viral Hepatitis D Relapses Upon Discontinuation of Antiviral Therapy With Bulevirtide in Patients With Chronic Hepatitis D and Negative HDV RNA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Probability of HDV relapse-free over time
研究概览
简要总结
This observational study will be conducted in patients with chronic co-infection with hepatitis B and D viruses, with negative PCR for HDV RNA in peripheral blood and no signs of active liver inflammation according to blood chemistry parameters, receiving background therapy with bulevirtide for more than 48 weeks and liver biopsy performed or prescribed to be performed as part of routine practice.
After the patient has signed the Informed Consent, a portion of the liver biopsy collected as part of routine practice will be sent to the laboratory for PCR testing for HDV RNA, background therapy with bulevirtide will be interrupted, and the patient will be observed in the clinic in accordance with routine medical practice, but at least once times every 4 weeks, for timely detection of relapse of the hepatitis D and initiation of antiviral therapy. Once a relapse of viral hepatitis D is determined via the PCR HDV RNA, the patient's participation in the study will be terminated.
The collected data will be analyzed to assess the probability of relapse-free over time. Separate tests will also be conducted for subgroups of patients based on covariates such as duration of previous background therapy with bulevirtide, duration of HDV suppression, use of any other concomitant antiviral therapy during bulevirtide treatment.
详细描述
The main goal of this study is the following:
- To assess the probability of HDV relapse-free over time after discontinuation of background therapy with bulevirtide in patients with chronic co-infection with hepatitis B and D viruses and negative PCR HDV RNA
Primary endpoint: Occurrence of hepatitis D viral relapse.
Additional objectives in this study:
- Analyze data on the time of relapse and the duration of previous background therapy with bulevirtide, the duration of the period of HDV suppression, and the use of any other concomitant antiviral therapy during the period of treatment with bulevirtide
- Analyze relapse-free patients over 96 weeks of study follow-up
- Analyze the results of qualitative PCR (positive / negative) for hepatitis D virus RNA in a liver biopsy before discontinuing bulevirtide therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of the patient to participate in the study, collect and use data
- •Age 18 or older
- •Background therapy with bulevirtide for at least 48 weeks
- •Negative qualitative PCR test for RNA of viral hepatitis D in peripheral blood before inclusion in the study
- •No active liver inflammation
- •Liver biopsy performed as part of routine practice (no older than 3 weeks before inclusion in the study) or prescribed biopsy to be performed before bulevirtide interruption
排除标准
- •Liver damage not related to viral hepatitis B and D - autoimmune hepatitis, drug or alcohol liver damage, Wilson-Konovalov disease, etc.
- •Co-infection with hepatitis C virus
- •Patients receiving HBV and HDV therapy not in accordance with standard practice or violations of the Instructions for the medical use of the drug/s
- •Moderate/severe renal/liver dysfunction
- •Lack of informed consent
结局指标
主要结局
Probability of HDV relapse-free over time
时间窗: 96 weeks
To assess the probability of HDV relapse-free over time discontinuation of background therapy with bulevirtide in patients with chronic co-infection with hepatitis B and D viruses and negative PCR HDV RNA
次要结局
- Probability of HDV relapse-free over time and the use of any other concomitant antiviral therapy during the period of treatment with bulevirtide(96 weeks)
- Probability of HDV relapse-free over time and the duration of previous background therapy with boulevertide(96 weeks)
- Relapse-free patients over 96 weeks(96 weeks)
- Results of qualitative PCR HDV RNA in a liver biopsy(Baseline (At the time of the patient inclusion))
- Probability of HDV relapse-free over time and the duration of the period of HDV suppression(96 weeks)