Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-29 @ 7:22 AM
Study NCT ID:
NCT04863703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2021-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003699', 'term': 'Hepatitis D'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718249', 'term': 'bulevirtide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-26', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change of Quality of life under viral suppression with Bulevirtide', 'timeFrame': 'Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.', 'description': 'Change of Quality of life is assessed via SF-36 questionnaire.'}, {'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.', 'description': 'Change in minimal HE status is evaluated via PSE-testing, critical flicker frequency and animal naming test.'}, {'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.', 'description': 'Change of nutritional status will be evaluated via repeated measurement of BMI (in kg/m2), arm circumference and triceps skin fold thickness.'}, {'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.', 'description': 'Change of physical ability is assessed via liver-frailty Index.'}, {'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.', 'description': '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.'}, {'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.', 'description': 'Change in liver stiffness will be assessed via transient elastography.'}, {'measure': 'Clinical endpoints under viral suppression with Bulevirtide', 'timeFrame': 'Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.', 'description': 'Assessed clinical endpoints are: Resolution of esophageal varices and incidence of esophageal bleeding, hepatic encephalopathy or ascites.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Portal hypertension, Liver cirrhosis, Bulevirtide, Hepatitis D, Hepatitis B'], 'conditions': ['Hepatitis D', 'Hepatitis B', 'Portal Hypertension', 'Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic HBV/HDV Coinfection\n* 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)\n* indication for antiviral treatment with Bulevirtide\n* age \\>18years\n* Must be willing to participate in the study and provide written informed consent\n\nExclusion Criteria:\n\n* patient rejects study participation\n* no conducted or no indication for HVPG measurement\n* age \\<18years'}, 'identificationModule': {'nctId': 'NCT04863703', 'acronym': 'IMPHROVE-D', 'briefTitle': 'Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)', 'orgStudyIdInfo': {'id': '9644_BO_S_2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'One group with HBV/HDV coinfection', 'description': '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.', 'interventionNames': ['Drug: Bulevirtide']}], 'interventions': [{'name': 'Bulevirtide', 'type': 'DRUG', 'description': 'Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.', 'armGroupLabels': ['One group with HBV/HDV coinfection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Benjamin Maasoumy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Benjamin Maasoumy', 'investigatorFullName': 'Maasoumy, Benjamin PD Dr', 'investigatorAffiliation': 'Hannover Medical School'}}}}