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

Baxalta

Status: Completed

Conditions: Protein C Deficiency

Treatments: Drug: Protein C Concentrate (Human) Vapor Heated

Study type: Observational

Funder types: Industry

Identifiers

NCT00161720

400501

Details and patient eligibility

About

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).

Enrollment: 11 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

11 participants in 1 patient group

All participants

Description:

Participants with severe congenital protein C deficiency who were treated under an emergency use IND.

Treatment:

Drug: Protein C Concentrate (Human) Vapor Heated