{ "data": { "asOf": "2026-10-30T22:24:35.263Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07446010", "title": "Post Approval Phase 4 Study to Learn More About How Safe Octocog Alfa is, and How Well it Works in Patients With Severe Hemophilia A in India", "scientificTitle": "A Prospective, Multicenter, Open-label, Phase IV Post-authorization Safety Study Conducted in India to Assess the Safety, and Treatment Outcomes of Octocog Alfa in Real-world Practice for On-demand Treatment of Acute Bleeds in Previously Treated Severe Hemophilia A Patients in India", "status": "not_yet_recruiting", "studyType": "observational", "phase": [], "conditions": [ "Hemophilia A", "Severe Hemophilia A" ], "interventions": [ { "name": "Octocog alfa", "type": "DRUG", "description": "unmodified, full-length recombinant human FVIII (rFVIII) dosing according to local label and treating physician" } ], "sponsor": { "name": "Bayer", "type": "INDUSTRY" }, "locations": [], "outcomes": { "other": [], "primary": [ "Duration of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)", "Severity of treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)", "Treatment administered for treatment emergent adverse event (TEAEs) and serious adverse events (TESAEs)", "Laboratory test results related to adverse events of special interest (AESIs)rse events (TESAEs)" ], "secondary": [ "Total number of infusions per bleed", "Dose of Octocog alfa (IU/kg) per bleed", "Location of bleeds", "Type of bleeds", "Severity of bleeds", "Duration of bleeds", "Investigator rating of response" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Male patients aged 18 years or older with a documented diagnosis of severe Hemophilia A, defined by a baseline Factor VIII (FVIII) activity level of less than 1% (\\<0.01 IU/mL) in accordance with the Hemophilia Severity Classification\n* Previously treated with FVIII concentrate(s) (plasma derived or recombinant, including Octocog alfa) either on-demand or prophylactically for at least 100 Exposure Days (EDs).\n* Patients for whom the decision to initiate on-demand treatment with Octocog alfa for acute bleeding was made as per the investigator's routine treatment practice. This will include patients who are already on on-demand treatment with Octocog alfa as well.\n* Written informed consent from the patient or legal representative\n\nExclusion Criteria:\n\n* Known contraindication according to the local prescriber information\n* Patients who are participating in an investigational program with interventions outside of routine clinical practice.\n* Patients with any other diagnosis of bleeding/coagulation disorder other than Hemophilia A.\n* Patients who are on ongoing prophylactic treatment with any FVIII concentrate or non-factor treatments like emicizumab.\n* Patients exhibiting any of the following laboratory abnormalities at screening:\n* Known platelet count \\<100,000 mm3\n* Known Serum Creatinine \\>2 folds upper the normal limit\n* Known Hepatic AST or ALT \\>5 folds upper the normal limit\n* Patients who have received an on-demand infusion with any other FVIII (different to Octocog alfa), FVII or Activated prothrombin complex concentrate product (aPCC/FEIBA) 72 hours before the enrollment.\n* History or presence of FVIII inhibitor with a titer ≥ 0.6 with Nijmegen modified Bethesda Assay (NBA), or a clinical history suggestive of an inhibitor necessitating changes to treatment\n* Patient concerns or other barriers precluding adequate understanding or cooperation.", "minimumAge": "18 Years" }, "enrollment": { "type": "ESTIMATED", "count": 30 }, "startDate": "2027-04-05", "completionDate": "2028-03-31", "lastUpdated": "2026-10-21T00:00:00.000Z", "firstPosted": "2026-03-03T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07446010" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07446010", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07446010", "sourceUrl": "https://clinicaltrials.gov/study/NCT07446010", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:32:06.528Z", "payloadSha256": "04c88ba8b6afe81912d93b0683385a863b971ecbafae4971af1db65047428916", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07446010", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07446010", "verifyAt": "https://clinicaltrials.gov/study/NCT07446010", "retrievedAt": "2026-10-28T04:32:06.528Z", "payloadSha256": "04c88ba8b6afe81912d93b0683385a863b971ecbafae4971af1db65047428916", "text": "ClinicalTrials.gov, record NCT07446010 (https://clinicaltrials.gov/study/NCT07446010), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07446010, registered in ClinicalTrials.gov, retrieved 2026-10-28. Verify at the source URLs listed; each retrieval is checksummed.", "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there." }, "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served." }, "_meta": { "api": "The Last Economy Wire: World Trials API", "version": "1.0", "schemaVersion": "1", "correlationId": "req_o5hjSeJPSiDx", "generatedAt": "2026-10-30T22:24:35.263Z", "documentation": "https://negativeresistance.com/embed", "license": "Free for any use. Attribution appreciated.", "degraded": false, "provenance": { "sources": [ "clinicaltrials_gov" ], "attribution": { "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs" }, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "limitations": [], "provenanceEndpoint": "/api/v1/sources" }, "freshness": { "newestEvidenceAt": null, "lastSyncedAt": { "clinicaltrials_gov": "2026-10-28T04:33:30.663Z" }, "degradedSources": [], "worldwide": false, "maxAgeHours": 65.9, "fromCache": false }, "links": { "discovery": "https://negativeresistance.com/api/v1", "openapi": "https://negativeresistance.com/api/v1/openapi.json", "mcp": "https://negativeresistance.com/api/v1/mcp", "agentCard": "https://negativeresistance.com/.well-known/agent.json", "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json", "sdk": "https://negativeresistance.com/api/v1/sdk", "status": "https://negativeresistance.com/api/v1/status", "provenance": "https://negativeresistance.com/api/v1/sources", "contract": "https://negativeresistance.com/api/v1/contract", "curriculum": "https://negativeresistance.com/api/v1/curriculum", "graph": "https://negativeresistance.com/api/v1/graph", "openQuestions": "https://negativeresistance.com/api/v1/open-questions", "scoreboard": "https://negativeresistance.com/api/v1/scoreboard", "findings": "https://negativeresistance.com/api/v1/findings", "claims": "https://negativeresistance.com/api/v1/claims", "threads": "https://negativeresistance.com/api/v1/threads", "assignment": "https://negativeresistance.com/api/v1/assignment", "changes": "https://negativeresistance.com/api/v1/changes", "hello": "https://negativeresistance.com/api/v1/hello", "errors": "https://negativeresistance.com/api/v1/errors", "webhooks": "https://negativeresistance.com/api/v1/webhooks", "a2a": "https://negativeresistance.com/api/v1/a2a", "deadEnds": "https://negativeresistance.com/api/v1/dead-ends", "decompositions": "https://negativeresistance.com/api/v1/decompositions", "rungs": "https://negativeresistance.com/api/v1/rungs", "methods": "https://negativeresistance.com/api/v1/methods", "reality": "https://negativeresistance.com/api/v1/reality", "council": "https://negativeresistance.com/api/v1/council", "calibration": "https://negativeresistance.com/api/v1/calibration", "freshness": "https://negativeresistance.com/api/v1/freshness", "mission": "https://negativeresistance.com/api/v1/mission", "twin": "https://negativeresistance.com/api/v1/twin", "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment", "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell", "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model", "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json", "collaborate": "https://negativeresistance.com/collaborate", "manifesto": "https://negativeresistance.com/about", "documentation": "https://negativeresistance.com/embed", "connect": "https://negativeresistance.com/connect", "llmsTxt": "https://negativeresistance.com/llms.txt", "llmsFullTxt": "https://negativeresistance.com/llms-full.txt" }, "disclaimer": "Research data from public registries and literature; not medical advice." } }