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

March 9, 2023 updated by: Maasoumy, Benjamin PD Dr, Hannover Medical School
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30625
        • Recruiting
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.
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.
Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
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.
Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
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.
Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
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.
Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
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.
Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide.
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.
Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Anticipated)

October 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9644_BO_S_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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