Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)

Recruiting

• Conditions: Hepatitis B; Hepatitis D; Portal Hypertension; Liver Cirrhosis
• Interventions: Drug: Bulevirtide

• Registration Number: NCT04863703
• Lead Sponsor: Hannover Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-28
• Study Start: 2021-05-07
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• 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

Exclusion Criteria

• patient rejects study participation
• no conducted or no indication for HVPG measurement
• age <18years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
One group with HBV/HDV coinfection	Bulevirtide	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.

Primary Outcome Measures

Name	Time	Method
Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide	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.

Secondary Outcome Measures

Name	Time	Method
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 physical ability is assessed via liver-frailty Index.
Change of Quality of life under viral suppression with Bulevirtide	Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.	Change of Quality of life is assessed via SF-36 questionnaire.
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 nutritional status will be evaluated via repeated measurement of BMI (in kg/m2), arm circumference and triceps skin fold thickness.
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 in minimal HE status is evaluated via PSE-testing, critical flicker frequency and animal naming test.
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 of the inflammatory profile will be assessed through Cytokines using Bio-Plex Pro Human Cytokine Screening Panel, 48-Plex, Bio-Rad, Olink Target 96 Inflammation and Olink Proteomics.
Change in liver stiffness under viral suppression with Bulevirtide	Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide.	Change in liver stiffness will be assessed via transient elastography.
Clinical endpoints under viral suppression with Bulevirtide	Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.	Assessed clinical endpoints are: Resolution of esophageal varices and incidence of esophageal bleeding, hepatic encephalopathy or ascites.

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Lower Saxony, Germany