Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide
研究概览
简要总结
Portal hypertension (PH) is one of the key drivers of clinical deteoration in patients with liver cirrhosis. It has been demonstrated that antiviral therapy in patients with chronic hepatitis C infection leads to a decrease of PH and is associated with an improved outcome. Recently, Bulevirtide was approved for the treatment of patients coinfected with hepatitis B (HBV) and chronic hepatitis delta (HDV) infection, which helps to achieve viral supression in these patients. This study investigates the potential effects of viral supression on PH in patients with chronic HBV/HDV infection and liver cirrhosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HBV/HDV Coinfection
- •suspected or diagnosed liver cirrhosis, indication for hepatovenous pressure gradient (HVPG) measurement or liver cirrhosis and HVPG measurement conducted in the past 12 months (conducted prior to antiviral treatment)
- •indication for antiviral treatment with Bulevirtide
- •age >18years
- •Must be willing to participate in the study and provide written informed consent
排除标准
- •patient rejects study participation
- •no conducted or no indication for HVPG measurement
- •age <18years
研究组 & 干预措施
One group with HBV/HDV coinfection
Measurement of HVPG before antiviral treatment of HBV/HDV coinfection and one year after treatment initiation with Bulevirtide. Administration of Bulevirtide and HVPG measurement is independent from this study.
干预措施: Bulevirtide (Drug)
结局指标
主要结局
Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide
时间窗: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change of hepatovenous pressure gradient (HVPG) in mmHg underviral suppression with Bulevirtide in patients with HBV/HDV coinfection and liver cirrhosis. HVPG measurement will be assessed via transjugular HVPG measurement.
次要结局
- Change of physical ability under viral suppression with Bulevirtide(Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.)
- Change of Quality of life under viral suppression with Bulevirtide(Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.)
- Change in minimal hepatic encephalopathy (HE) status under viral suppression(Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.)
- Change of nutritional status under viral suppression with Bulevirtide(Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.)
- Change of the inflammatory profile under viral suppression with Bulevirtide(Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.)
- Change in liver stiffness under viral suppression with Bulevirtide(Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide.)
- Clinical endpoints under viral suppression with Bulevirtide(Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.)
研究者
Maasoumy, Benjamin PD Dr
PD Dr. med. Benjamin Maasoumy
Hannover Medical School