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

Hannover Medical School (MHH)

Status: Active, not recruiting

Conditions: Hepatitis D; Portal Hypertension; Liver Cirrhosis; Hepatitis B

Treatments: Drug: Bulevirtide

Study type: Observational

Funder types: Other

Identifiers

NCT04863703

9644_BO_S_2021

Details and patient eligibility

About

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.

Enrollment: 11 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

One group with HBV/HDV coinfection

Description:

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.

Treatment:

Drug: Bulevirtide