Hepatitis DIMPHROVE-DNCT04863703
Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
An observational study of Hepatitis D and Hepatitis B, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis D, Hepatitis B, Portal Hypertension
- What is being tested?
- Bulevirtide
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 7 May 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- patient rejects study participation
- no conducted or no indication for HVPG measurement
- age <18years
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Bulevirtide
- Keywords
- Portal hypertension, Liver cirrhosis, Bulevirtide, Hepatitis D, Hepatitis B
- Medical subject headings
- Hepatitis D, Hepatitis B, Hypertension, Portal, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulevirtideDrug
Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bulevirtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change of Quality of life is assessed via SF-36 questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start7 May 2021
- Primary completion30 Nov 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maasoumy, Benjamin PD Dr, Hannover Medical School
- Investigators
- Benjamin Maasoumy, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863703
- Sponsor's protocol ID
- 9644_BO_S_2021
- Acronym
- IMPHROVE-D
- Status last verified
- Mar 2025
- First submitted
- 13 Apr 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41674894
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
- ClinicalTrials.gov ID
- NCT04863703
- Acronym / sponsor ID
- IMPHROVE-D / 9644_BO_S_2021
- Conditions
- Hepatitis D, Hepatitis B, Portal Hypertension, Liver Cirrhosis
- Keywords
- Portal hypertension, Liver cirrhosis, Bulevirtide, Hepatitis D, Hepatitis B
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group with HBV/HDV coinfection | – | Drug: BulevirtideMeasurement 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- patient rejects study participation
- no conducted or no indication for HVPG measurement
- age <18years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BulevirtidePatients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational. | Drug | One group with HBV/HDV coinfection |
Primary outcome
Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression 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.
7 secondary outcomes
Change of Quality of life under viral suppression with Bulevirtide
Time frame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.
Change in minimal hepatic encephalopathy (HE) status under viral suppression
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
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
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
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
Time frame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide.
Clinical endpoints under viral suppression with Bulevirtide
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 41674894Sandmann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Maasoumy, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis D and Hepatitis B, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide (time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.