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Active, Not Recruiting

NCT Number: NCT04863703

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatitis D Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Hypertension, Portal Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bulevirtide

Drug

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change of Quality of life under viral suppression with Bulevirtide

    Time frame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.

    Change of Quality of life is assessed via SF-36 questionnaire.

  2. Change in minimal hepatic encephalopathy (HE) status under viral suppression

    Time frame: 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.

  3. Change of nutritional status under viral suppression with Bulevirtide

    Time frame: 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.

  4. Change of physical ability under viral suppression with Bulevirtide

    Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.

    Change of physical ability is assessed via liver-frailty Index.

  5. Change of the inflammatory profile under viral suppression with Bulevirtide

    Time frame: 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.

  6. Change in liver stiffness under viral suppression with Bulevirtide

    Time frame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide.

    Change in liver stiffness will be assessed via transient elastography.

  7. Clinical endpoints under viral suppression with Bulevirtide

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Acronym: IMPHROVE-D

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Apr 28, 2021
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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