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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00161720

Enrollment

Registered

2005-09-13

Start date

2005-06-01

Completion date

2005-12-01

Last updated

2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein C Deficiency

Keywords

Severe Congenital Protein C Deficiency

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).

Interventions

DRUGProtein C Concentrate (Human) Vapor Heated

Protein C Concentrate (Human) Vapor Heated

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants who Received a Dose of Protein C in Retrospective Study	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	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	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	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026