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Coagulation Factor VIII Replacement

Haemophilia A Group for Hemophilia A

N/A
Waitlist Available
Research Sponsored by Baxalta now part of Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Awards & highlights

Summary

The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events (AE) Related to Impaired Hepatic Function
Number of Participants With Adverse Events (AE) Related to Impaired Neurologic Function
Number of Participants With Adverse Events (AE) Related to Impaired Renal Function
+2 more
Secondary outcome measures
Change From Baseline in Alanine Aminotransferase (ALT) at Specified Time Points
Change From Baseline in Bilirubin at Specified Time Points
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Specified Time Points
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Haemophilia A GroupExperimental Treatment1 Intervention
Participants with haemophilia A in the study will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national summary of product characteristics (SmPC).

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Who is running the clinical trial?

Baxalta now part of ShireLead Sponsor
110 Previous Clinical Trials
8,891 Total Patients Enrolled
52 Trials studying Hemophilia A
3,830 Patients Enrolled for Hemophilia A
Study DirectorStudy DirectorShire
1,252 Previous Clinical Trials
504,172 Total Patients Enrolled
66 Trials studying Hemophilia A
4,832 Patients Enrolled for Hemophilia A
~117 spots leftby Feb 2030
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