Trial · NCT04863703
Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
NCT04863703, Active not recruiting, Hannover Medical School
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D). Trials, record NCT04863703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04863703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
- NCT number
- NCT04863703
- Status
- Active not recruiting
- Enrollment
- 11 participants, estimated
- Lead sponsor
- Hannover Medical School
- Conditions
- Hepatitis D, Hepatitis B, Portal Hypertension, Liver Cirrhosis
- Interventions
- Bulevirtide
- First posted
- 2021-04-28
- Last updated
- 2025-09-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide | 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. |
| Secondary | Change of Quality of life under viral suppression with Bulevirtide | Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment. | Change of Quality of life is assessed via SF-36 questionnaire. |
| Secondary | Change in minimal hepatic encephalopathy (HE) status under viral suppression | Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide. | Change in minimal HE status is evaluated via PSE-testing, critical flicker frequency and animal naming test. |
| Secondary | Change of nutritional status under viral suppression with Bulevirtide | Measurement before antiviral treatment (baseline) and one year after inducing 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. |
| Secondary | Change of physical ability under viral suppression with Bulevirtide | Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide. | Change of physical ability is assessed via liver-frailty Index. |
| Secondary | Change of the inflammatory profile under viral suppression with Bulevirtide | Measurement before antiviral treatment (baseline) and one year after inducing 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. |
| Secondary | Change in liver stiffness under viral suppression with Bulevirtide | Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide. | Change in liver stiffness will be assessed via transient elastography. |
| Secondary | Clinical endpoints under viral suppression with Bulevirtide | Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide. | Assessed clinical endpoints are: Resolution of esophageal varices and incidence of esophageal bleeding, hepatic encephalopathy or ascites. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41674894 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Category Fluency | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04863703
GET https://conductscience.org/api/trials/v1/NCT04863703/registered