CompletedNot Applicable

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

United States11 participantsStarted 2005-06-01

Plain-language 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).

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants who Received a Dose of Protein C in Retrospective Study

Timeframe: Throughout the study period (up to 6 months)

Number of Participants with Prophylactic Treatment Outcome

Timeframe: Throughout the study period (up to 6 months)

Number of Participants with Acute Episode Treatment Outcome

Timeframe: Throughout the study period (up to 6 months)

Number of Participants with Adverse Experiences (AEs) Related to Protein C Concentrate Treatment

Timeframe: Throughout the study period (up to 6 months)

Trial details

NCT IDNCT00161720

SponsorBaxalta now part of Shire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2005-12-01

View on ClinicalTrials.gov More Protein C Deficiency trials