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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulevirtide | Drug | Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Quality of life under viral suppression with Bulevirtide | Change of Quality of life is assessed via SF-36 questionnaire. | Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment. |
| Change in minimal hepatic encephalopathy (HE) status under viral suppression |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Maasoumy, MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41674894 | Derived | Sandmann L, Jachs M, Tergast TL, Hartl L, Bremer B, Kabelitz MA, Schwarz M, Egge JFM, Balcar L, Hofer BS, Falk CS, Stattermayer AF, Cornberg M, Trauner M, Deterding K, Mandorfer M, Wedemeyer H, Reiberger T, Maasoumy B. Treatment response to bulevirtide is linked to amelioration of portal hypertension in patients with chronic hepatitis D. JHEP Rep. 2025 Oct 17;8(1):101643. doi: 10.1016/j.jhepr.2025.101643. eCollection 2026 Jan. |
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| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006509 | Hepatitis B |
| D006975 | Hypertension, Portal |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000718249 | bulevirtide |
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Change in minimal HE status is evaluated via PSE-testing, critical flicker frequency and animal naming test. |
| 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. | 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. | 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. | 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. | 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. | Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide. |
| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |