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 Type
OBSERVATIONAL
Enrollment
11
Protein C Concentrate (Human) Vapor Heated
Children´s Hospital of Los Angeles
Los Angeles, California, United States
Children´s Hospital Denver
Denver, Colorado, United States
Evans Army Hospital
Fort Carson, Colorado, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Throughout the study period (up to 6 months)
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Children´s Hospital Boston
Boston, Massachusetts, United States
Rainbow Babies & Children´s Hospital
Cleveland, Ohio, United States
The Children´s Medical Center - Dayton
Dayton, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Cook Children´s Medical Center
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Texas Children´s Hospital
Houston, Texas, United States