An observational study in Hepatitis D, Hepatitis B and Portal Hypertension, sponsored by Hannover Medical School. Active, not recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Hannover Medical School · Observational
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.
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's planned enrollment of 11 is below the median of 326 across 29 observational studies indexed under Hepatitis D.
Browse Hepatitis D studies →Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change of Quality of life under viral suppression with Bulevirtide
Change of Quality of life is assessed via SF-36 questionnaire.
Time frame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.
Change in minimal hepatic encephalopathy (HE) status under viral suppression
Change in minimal HE status is evaluated via PSE-testing, critical flicker frequency and animal naming test.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change of nutritional status under 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.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change of physical ability under viral suppression with Bulevirtide
Change of physical ability is assessed via liver-frailty Index.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change of the inflammatory profile under 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.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change in liver stiffness under viral suppression with Bulevirtide
Change in liver stiffness will be assessed via transient elastography.
Time frame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide.
Clinical endpoints under viral suppression with Bulevirtide
Assessed clinical endpoints are: Resolution of esophageal varices and incidence of esophageal bleeding, hepatic encephalopathy or ascites.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Plan to share: Undecided
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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