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

NCT04863703 · tracked via the Priya Life Science Germany tracker

Sponsor

Hannover Medical School

Phase

Observational

Started

2021-05-07

Last updated

2025-09-15

Condition(s) studied

Hepatitis DHepatitis BPortal HypertensionLiver Cirrhosis

Investigational drug(s) / intervention(s)

Bulevirtide →

Bulevirtide: Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Hannover Medical School	Hanover	Lower Saxony

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04863703 on ClinicalTrials.gov ↗ ← All trials in Germany