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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-01

Study Completion Date

2005-12-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Protein C Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All participants

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

Protein C Concentrate (Human) Vapor Heated

Intervention Type DRUG

Protein C Concentrate (Human) Vapor Heated

Interventions

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Protein C Concentrate (Human) Vapor Heated

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No