Hemophilia Non-Interventional Study Prior to SerpinPC Intervention (PRESent-5)
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|ClinicalTrials.gov Identifier: NCT05605678|
Recruitment Status : Recruiting
First Posted : November 4, 2022
Last Update Posted : November 2, 2023
|Condition or disease||Intervention/treatment|
|Hemophilia A Hemophilia B||Other: No Intervention|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||A Global, Non-interventional Study to Prospectively Evaluate Bleeding Episodes and Treatment Use in Patients With Hemophilia|
|Actual Study Start Date :||December 9, 2022|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2024|
All Eligible Participants
All Participants diagnosed with severe HemA with or without inhibitors, moderately severe to severe HemB, or HemB with inhibitors will be enrolled and continue to receive their usual hemophilia treatment regimen under SOC therapy. Bleeding episodes and treatment data will be collected during the prospective follow up period in a diary. No intervention will be administered as part of this study.
Other: No Intervention
This is a non-interventional study.
- Annualized Bleeding Rate (ABR) for Treated Bleeds and All Bleeds [ Time Frame: Minimum 12 weeks ]ABR for treated bleeds and all bleeds at the participant and bleed level (excluding bleeding episodes during surgery and/or procedures).
- Average Dose (IU/kg) of Associated Treatment Received for Bleeding Episodes per Hemophilia Product per Time Period and per Bleeding Episode [ Time Frame: Minimum 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05605678
|Contact: Centessa Pharmaceuticals||617 468 firstname.lastname@example.org|