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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

Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Protein C Deficiency

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

Phase: Phase 4

Status: Completed

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Taru Hays, MD, Principal Investigator, Affiliation: Children´s Hospital, Denver, CO, USA

Summary

This is a data collection study with the purpose of capturing dosing and treatment outcome data in subjects with severe congenital protein C deficiency who were treated with protein C concentrate under an Emergency Use Investigational New Drug Application (IND).

Clinical Details

Official title: 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

Study design: Time Perspective: Retrospective

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject treated with protein C concentrate under a Baxter Healthcare Corporation

Emergency Use IND

- Subject with diagnosis of severe congenital protein C deficiency

- Subject or parent/legally authorized representative has provided written informed

consent

Locations and Contacts

Children´s Hospital of Los Angeles, Los Angeles, California 90027, United States

Children´s Hospital Denver, Denver, Colorado 80218, United States

Evans Army Hospital, Fort Carson, Colorado 80973, United States

Children´s Hospital Boston, Boston, Massachusetts 02115, United States

Rainbow Babies & Children´s Hospital, Cleveland, Ohio 44106, United States

The Children´s Medical Center - Dayton, Dayton, Ohio 45404, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Cook Children´s Medical Center, Fort Worth, Texas 76104, United States

University of Texas Medical Branch, Galveston, Texas 77555, United States

Texas Children´s Hospital, Houston, Texas 80218, United States

Additional Information

Starting date: June 2005
Last updated: June 26, 2015

Page last updated: August 20, 2015

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