CClinicalTrials.gg
Sign In
Active, not recruitingNCT04863703IMPHROVE-DUpdated Sep 15, 2025

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

An observational study in Hepatitis D, Hepatitis B and Portal Hypertension, sponsored by Hannover Medical School. Active, not recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Hannover Medical School · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
11
Sex
All
01

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.

02

Conditions studied

  • Hepatitis D
  • Hepatitis B
  • Portal Hypertension
  • Liver Cirrhosis

Keywords

  • Portal hypertension, Liver cirrhosis, Bulevirtide, Hepatitis D, Hepatitis B
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study populations consists out of patients with HBV/HDV coinfection, diagnosed or suspected liver cirrhosis. All patients must have a medical indication for HVPG measurement or had a HVPG measurement within the last 12 months.

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

Exclusion Criteria:

  • patient rejects study participation
  • no conducted or no indication for HVPG measurement
  • age \<18years
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
11 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Drug: Bulevirtide

Interventions

  • DrugBulevirtide

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

05

What researchers measure

Primary outcomes

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

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

Secondary outcomes

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

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

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

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

    Change in minimal HE status is evaluated via PSE-testing, critical flicker frequency and animal naming test.

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

  3. Change of nutritional status under 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.

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

  4. Change of physical ability under viral suppression with Bulevirtide

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

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

  5. Change of the inflammatory profile under 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.

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

  6. Change in liver stiffness under viral suppression with Bulevirtide

    Change in liver stiffness will be assessed via transient elastography.

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

  7. Clinical endpoints under viral suppression with Bulevirtide

    Assessed clinical endpoints are: Resolution of esophageal varices and incidence of esophageal bleeding, hepatic encephalopathy or ascites.

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

06

Study locations

1 site
  • Hannover Medical School
    Hanover, Lower Saxony 30625, Germany
07

References and documents

Publications

  • Sandmann L, Jachs M, Tergast TL, Hartl L, Bremer B, Kabelitz MA, Schwarz M, Egge JFM, Balcar L, Hofer BS, Falk CS, Stattermayer AF, Cornberg M, Trauner M, Deterding K, Mandorfer M, Wedemeyer H, Reiberger T, Maasoumy B. Treatment response to bulevirtide is linked to amelioration of portal hypertension in patients with chronic hepatitis D. JHEP Rep. 2025 Oct 17;8(1):101643. doi: 10.1016/j.jhepr.2025.101643. eCollection 2026 Jan. PubMed 41674894 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT04863703
Lead sponsor
Hannover Medical School
Responsible party
Maasoumy, Benjamin PD Dr (PD Dr. med. Benjamin Maasoumy, Hannover Medical School) — Principal investigator
First posted
Apr 28, 2021
Start date
May 7, 2021
Primary completion
Nov 30, 2024
Completion
Dec 31, 2026 (estimated)
Last update
Sep 15, 2025

Study contacts

Benjamin Maasoumy, MD
principal investigator · Hannover Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis D→

Other studies from this sponsor

Hannover Medical School

Start the discussion