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

NCT ID: NCT04863703

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-07

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Hepatitis D Hepatitis B Portal Hypertension Liver Cirrhosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bulevirtide

Intervention Type DRUG

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

Interventions

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Bulevirtide

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Maasoumy, Benjamin PD Dr

PD Dr. med. Benjamin Maasoumy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin Maasoumy, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Hannover Medical School

Hanover, Lower Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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9644_BO_S_2021

Identifier Type: -

Identifier Source: org_study_id

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