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

NCT04863703 | Active Not Recruiting

• 1 other identifier: 9644_BO_S_2021
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis D; Hepatitis B; Portal Hypertension; Liver Cirrhosis

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (7)

• Change of Quality of life under viral suppression with Bulevirtide

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

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

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

• Change of nutritional status under viral suppression with Bulevirtide

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

• Change of physical ability under viral suppression with Bulevirtide

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

• Change of the inflammatory profile under viral suppression with Bulevirtide

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

Study Arms (1)

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

Bulevirtide DRUG

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

One group with HBV/HDV coinfection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Hepatitis D; Hepatitis B; Hypertension, Portal; Liver Cirrhosis

Interventions

bulevirtide

Condition Hierarchy (Ancestors)

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

Study Officials

• Benjamin Maasoumy, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Benjamin Maasoumy

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 28, 2021
• Study Start: May 7, 2021
• Primary Completion: November 30, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-03

Locations

DE (1)