Retrospective Study to Capture Dosing and Treatment Outcome Data in Participants With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND

Study Overview
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Brief Summary
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This is a data collection study with the purpose of capturing dosing and treatment outcome data in participants with severe congenital protein C deficiency who were treated with protein C concentrate under an Emergency Use Investigational New Drug Application (IND).

Official Title
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A Retrospective Study to Capture Dosing and Treatment Outcome Data in Subjects With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND

Conditions
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Protein C Deficiency

Intervention / Treatment
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* Drug: Protein C Concentrate (Human) Vapor Heated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant treated with protein C concentrate under a Baxter Healthcare Corporation Emergency Use IND. Participant with diagnosis of severe congenital protein C deficiency. Participant or parent/legally authorized representative has provided written informed consent.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Participants with severe congenital protein C deficiency who were treated under an emergency use IND. | Drug: Protein C Concentrate (Human) Vapor Heated<br>* Protein C Concentrate (Human) Vapor Heated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Received a Dose of Protein C in Retrospective Study | Number of participants who received a dose of Protein C in retrospective study will be reported. | Throughout the study period (up to 6 months) | 
| Number of Participants with Prophylactic Treatment Outcome | Participants experience any episodes of purpura fulminans (PF), coumarin induced skin necrosis (CISN), or thromboembolic event during prophylactic treatment will be assessed. | Throughout the study period (up to 6 months) | 
| Number of Participants with Acute Episode Treatment Outcome | Acute episode treatment outcome includes type of episode (PF, CISN, Thromboembolic); Was treatment effective or not effective; Was patient successfully transitioned to anticoagulation following the resolution of the episode will be assessed. | Throughout the study period (up to 6 months) | 
| Number of Participants with Adverse Experiences (AEs) Related to Protein C Concentrate Treatment | An AE is defined as any untoward medical occurrence in a participant administered study product that does not necessarily have a casual relationship with the treatment. AEs considered possibly or probably related to Protein C Concentrate treatment will be recorded on case report forms (CRFs). | Throughout the study period (up to 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Congenital Protein C Deficiency