{ "data": { "asOf": "2026-10-30T22:26:47.713Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT05932914", "title": "Liver Biopsy Following Gene Therapy For Hemophilia", "scientificTitle": "Liver Biopsy Following Gene Therapy For Hemophilia", "status": "not_yet_recruiting", "studyType": "observational", "phase": [], "conditions": [ "Hemophilia A", "Hemophilia B" ], "interventions": [ { "name": "Liver Biopsy", "type": "PROCEDURE", "description": "Standard transjugular liver biopsy under moderate sedation" } ], "sponsor": { "name": "St. Jude Children's Research Hospital", "type": "OTHER" }, "locations": [ { "city": "Memphis", "country": "United States", "facility": "St. Jude Children's Research Hospital" } ], "outcomes": { "other": [], "primary": [ "Assessment of the number of hepatocytes transduced with AAV vector genome in liver biopsy samples analyzed by FISH" ], "secondary": [ "The degree of hepatocyte damage at a morphological level", "The number and type of hot spots for integration of AAV provirus in liver cells", "The number of hepatocytes revealing FVIII/FIX RNA in-situ transcripts", "The number and types of epigenetic changes within the AAV genome in the liver", "The qualitative and quantitative assessment of the RNA transcriptome" ] }, "eligibility": { "sex": "MALE", "criteria": "Inclusion Criteria:\n\n* Age ≥18 to 80 years\n* Patients, who were enrolled and treated in one of the following clinical trials:\n\n * AGT4HB (EudraCT number: 2005-005711-17; NCT00979238) - FIX AAV gene therapy trial (sponsor: St. Jude Children's Research Hospital)\n * GO8 (EudraCT number:2014-003880-38; NCT02576795) - FVIII AAV gene therapy trial (sponsor: University College, London)\n* Able to give informed consent\n* Able to comply with study requirements\n\nExclusion Criteria (Do not apply to participants who will not undergo liver biopsy, and have leftover liver tissue from a previous biopsy procedure, because all exclusion criteria only cover the safety considerations for the biopsy procedure.):\n\n* Any condition that, in the opinion of the investigator or sponsor of the ongoing clinical trial in which the patient is participating in, would prevent the patient from fully complying with the requirements of the clinical trial and/or would influence or interfere with evaluation and interpretation of subject safety or efficacy result of that ongoing clinical trial\n* Platelet count \\<140x10\\^9/L\n* INR \\>1.5\n* Abnormal kidney function with estimated GFR \\<50 mL/min (calculated using the CKD-EPI equation)\n* Known allergy to iodine-based intravenous contrast agents\n* Known allergy to local or general anesthetics\n* Known allergic reaction to FVIII/FIX concentrate infusions\n* Presence of FVIII inhibitor or FIX inhibitor (historical result can be used if done within 14 weeks of this liver biopsy)\n* Evidence of any bleeding disorder other than hemophilia A or B", "maximumAge": "80 Years", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 8 }, "startDate": "2026-11-01", "completionDate": "2030-01-01", "lastUpdated": "2026-10-22T00:00:00.000Z", "firstPosted": "2023-07-06T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT05932914" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT05932914", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT05932914", "sourceUrl": "https://clinicaltrials.gov/study/NCT05932914", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:32:06.527Z", "payloadSha256": "c26a6ecb881121f269635268c3211a189035812a91aa899f2bfd678e6391a0bb", "piiRedacted": true } ], "citation": { "canonicalId": "NCT05932914", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT05932914", "verifyAt": "https://clinicaltrials.gov/study/NCT05932914", "retrievedAt": "2026-10-28T04:32:06.527Z", "payloadSha256": "c26a6ecb881121f269635268c3211a189035812a91aa899f2bfd678e6391a0bb", "text": "ClinicalTrials.gov, record NCT05932914 (https://clinicaltrials.gov/study/NCT05932914), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT05932914, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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