Trial record 2 of 3 for:    "Protein C deficiency"

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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161720
First received: September 8, 2005
Last updated: January 29, 2007
Last verified: October 2006
  Purpose

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).


Condition Intervention Phase
Protein C Deficiency
Drug: Protein C Concentrate (Human) Vapor Heated
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: June 2005
Estimated Study Completion Date: December 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161720

Locations
United States, California
Children´s Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
Children´s Hospital Denver
Denver, Colorado, United States, 80218
Evans Army Hospital
Fort Carson, Colorado, United States, 80973
United States, Massachusetts
Children´s Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Ohio
Rainbow Babies & Children´s Hospital
Cleveland, Ohio, United States, 44106
The Children´s Medical Center - Dayton
Dayton, Ohio, United States, 45404
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Cook Children´s Medical Center
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Texas Children´s Hospital
Houston, Texas, United States, 80218
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Taru Hays, MD Children´s Hospital, Denver, CO, USA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00161720     History of Changes
Other Study ID Numbers: 400501
Study First Received: September 8, 2005
Last Updated: January 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:
Severe Congenital Protein C Deficiency

Additional relevant MeSH terms:
Protein C Deficiency
Emergencies
Disease Attributes
Pathologic Processes
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Thrombophilia
Genetic Diseases, Inborn
Protein C
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014