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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 10
- Primary Endpoint
- Number of Participants who Received a Dose of Protein C in Retrospective Study
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Arms & Interventions
All participants
Participants with severe congenital protein C deficiency who were treated under an emergency use IND.
Intervention: Protein C Concentrate (Human) Vapor Heated (Drug)
Outcomes
Primary Outcomes
Number of Participants who Received a Dose of Protein C in Retrospective Study
Time Frame: Throughout the study period (up to 6 months)
Number of participants who received a dose of Protein C in retrospective study will be reported.
Number of Participants with Prophylactic Treatment Outcome
Time Frame: Throughout the study period (up to 6 months)
Participants experience any episodes of purpura fulminans (PF), coumarin induced skin necrosis (CISN), or thromboembolic event during prophylactic treatment will be assessed.
Number of Participants with Acute Episode Treatment Outcome
Time Frame: Throughout the study period (up to 6 months)
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.
Number of Participants with Adverse Experiences (AEs) Related to Protein C Concentrate Treatment
Time Frame: Throughout the study period (up to 6 months)
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).
Secondary Outcomes
No secondary outcomes reported