Clinical trial NCT04863703: Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
Official title: Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis D
Hepatitis B
Portal Hypertension
Liver Cirrhosis
Keywords: Portal hypertension, Liver cirrhosis, Bulevirtide, Hepatitis D, Hepatitis B
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide
timeFrame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Secondary outcomes:
measure: Change of Quality of life under viral suppression with Bulevirtide
timeFrame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.
measure: Change in minimal hepatic encephalopathy (HE) status under viral suppression
timeFrame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
measure: Change of nutritional status under viral suppression with Bulevirtide
timeFrame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
measure: Change of physical ability under viral suppression with Bulevirtide
timeFrame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
measure: Change of the inflammatory profile under viral suppression with Bulevirtide
timeFrame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
measure: Change in liver stiffness under viral suppression with Bulevirtide
timeFrame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide.
measure: Clinical endpoints under viral suppression with Bulevirtide
timeFrame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School
name: Benjamin Maasoumy, MD
role: PRINCIPAL_INVESTIGATOR
References: