CLINICAL_TRIALS ClinicalTrials.gov record update

AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, LEAD-IN STUDY TO EVALUATE AT LEAST 6 MONTHS OF PROSPECTIVE EFFICACY AND SAFETY DATA OF FACTOR IX OR FACTOR VIII PROPHYLAXIS REPLACEMENT THERAPY IN THE USUAL CARE SETTING OF MODERATELY SEVERE TO SEVERE ADULT HEMOPHILIA B SUBJECTS (FIX:C≤2%) WHO ARE NEGATIVE FOR nAb TO AAV VECTOR-SPARK100 AND MODERATELY SEVERE TO SEVERE HEMOPHILIA A ADULT SUBJECTS (FVIII:C≤1%) WHO ARE NEGATIVE FOR nAb TO AAV VECTOR SB-525 CAPSID (AAV6), PRIOR TO THE RESPECTIVE THERAPEUTIC PH 3 GENE THERAPY STUDIES (See Detailed Description Section for Official Protocol Title)

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT03587116
Title field or adapter rule: protocolSection.identificationModule.officialTitle
Ingested At: 2026-04-25T22:29:00.212036+00:00
Published At: 2025-11-06T00:00:00+00:00
Record Updated At: 2025-11-06
Results Posted At: 2025-11-06
Timestamp Basis: source retrieval time was not retained by the feed adapter
Date limitation: source retrieval time was not retained by the feed adapter

protocolSection.conditionsModule.conditions: ["Hemophilia B", "Hemophilia A"]
protocolSection.statusModule.lastUpdatePostDateStruct.date: "2025-11-06"
protocolSection.identificationModule.nctId: "NCT03587116"
protocolSection.identificationModule.officialTitle: "AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, LEAD-IN STUDY TO EVALUATE AT LEAST 6 MONTHS OF PROSPECTIVE EFFICACY AND SAFETY DATA OF FACTOR IX OR FACTOR VIII PROPHYLAXIS REPLACEMENT THERAPY IN THE USUAL CARE SETTING OF MODERATELY SEVERE TO SEVERE ADULT HEMOPHILIA B SUBJECTS (FIX:C\u22642%) WHO ARE NEGATIVE FOR nAb TO AAV VECTOR-SPARK100 AND MODERATELY SEVERE TO SEVERE HEMOPHILIA A ADULT SUBJECTS (FVIII:C\u22641%) WHO ARE NEGATIVE FOR nAb TO AAV VECTOR SB-525 CAPSID (AAV6), PRIOR TO THE RESPECTIVE THERAPEUTIC PH 3 GENE THERAPY STUDIES (See Detailed Description Section for Official Protocol Title)"
protocolSection.statusModule.overallStatus: "COMPLETED"
protocolSection.designModule.phases: ["PHASE3"]
protocolSection.statusModule.resultsFirstPostDateStruct.date: "2025-11-06"

Intervention details are not present in the imported fields for this record. No drug-condition relationship is inferred from co-listing.

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