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

Completed

Conditions studied: Protein C Deficiency

In brief

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).

Key facts

Study ID

NCT00161720

Run by

Baxalta now part of Shire

People needed

11

Starts

2005-06-01

Expected to finish

2005-12-01

Last updated by the study team

2021-04-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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