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      "canonicalId": "NCT07088458",
      "title": "An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A",
      "scientificTitle": "An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A",
      "status": "recruiting",
      "studyType": "observational",
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      "conditions": [
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          "name": "Damoctocog alfa pegol (Jivi, Bay94-9027)",
          "type": "DRUG",
          "description": "Follow clinical practice of BAY94-9027 to further define the treatment outcomes of damoctocog alfa pegol based on real-world use for regular prophylaxis in ages 7 to \\<12 years, including a broader population and a real-world treatment patterns."
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        "type": "INDUSTRY"
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      "locations": [
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          "city": "Loma Linda",
          "country": "United States",
          "facility": "Loma Linda University Health"
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        {
          "city": "New Brunswick",
          "country": "United States",
          "facility": "Rutgers, The State University"
        },
        {
          "city": "Many Locations",
          "country": "Brazil",
          "facility": "Many locations"
        },
        {
          "city": "Many Locations",
          "country": "Canada",
          "facility": "Many locations"
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        {
          "city": "Many Locations",
          "country": "Colombia",
          "facility": "Many locations"
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        {
          "city": "Many Locations",
          "country": "Denmark",
          "facility": "Many locations"
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          "city": "Many Locations",
          "country": "Italy",
          "facility": "Many locations"
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          "city": "Many Locations",
          "country": "Japan",
          "facility": "Many locations"
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          "city": "Many Locations",
          "country": "Lithuania",
          "facility": "Many locations"
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          "city": "Many Locations",
          "country": "Mexico",
          "facility": "Many locations"
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          "city": "Many Locations",
          "country": "Norway",
          "facility": "Many locations"
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          "city": "Many Locations",
          "country": "Spain",
          "facility": "Many locations"
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          "Occurrence of bleeds during individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis prescription (overall and by dosing regimen)",
          "Occurrence of bleeds within 6 months' time intervals including the first and the last 6 months during observation period (overall and by dosing regimen)",
          "Presence of target joints at enrollment and at end of prophylaxis prescription (overall and by dosing regimen)",
          "Damoctocog alfa pegol dose per infusion (overall and by dosing regimen)",
          "Number of FVIII infusions (overall and by dosing regimen)"
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        "criteria": "Inclusion Criteria:\n\n* Diagnosis of hemophilia A\n* Patients must be 7 to \\< 12 years of age at enrollment\n* Patients previously treated for hemophilia A ((≥50 exposure days to FVIII)\n* No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor\n* Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry\n* Initiation of prescription or currently prescribed damoctocog alfa pegol for regular continuous prophylaxis (intent to treat for 52 weeks/year)\n* Signed informed consent/assent.\n\nExclusion Criteria:\n\n* Presence of a FVIII inhibitor\n* Concurrent participation in an investigational program with interventions outside of routine clinical practice\n* Diagnosis of any other bleeding/coagulation disorder other than hemophilia A\n* Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period\n* Contra-indications according to the local marketing authorization\n* Current immune tolerance induction (ITI) treatment for a FVIII inhibitor",
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        "count": 40
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      "completionDate": "2030-03-01",
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