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

Protein C Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161720
• Other study ID #: 400501
• Status: Completed
• Start date: June 1, 2005
• Est. completion date: December 1, 2005

Study information

• Verified date: April 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 1, 2005
• Est. primary completion date: December 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Protein C Deficiency

Intervention

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

Locations

Country	Name	City	State
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	Children´s Hospital Denver	Denver	Colorado
United States	Evans Army Hospital	Fort Carson	Colorado
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	Children´s Hospital of Los Angeles	Los Angeles	California
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Received a Dose of Protein C in Retrospective Study	Number of participants who received a dose of Protein C in retrospective study will be reported.	Throughout the study period (up to 6 months)
Primary	Number of Participants with Prophylactic Treatment Outcome	Participants experience any episodes of purpura fulminans (PF), coumarin induced skin necrosis (CISN), or thromboembolic event during prophylactic treatment will be assessed.	Throughout the study period (up to 6 months)
Primary	Number of Participants with Acute Episode Treatment Outcome	Acute episode treatment outcome includes type of episode (PF, CISN, Thromboembolic); Was treatment effective or not effective; Was patient successfully transitioned to anticoagulation following the resolution of the episode will be assessed.	Throughout the study period (up to 6 months)
Primary	Number of Participants with Adverse Experiences (AEs) Related to Protein C Concentrate Treatment	An AE is defined as any untoward medical occurrence in a participant administered study product that does not necessarily have a casual relationship with the treatment. AEs considered possibly or probably related to Protein C Concentrate treatment will be recorded on case report forms (CRFs).	Throughout the study period (up to 6 months)

External Links

•   To obtain more information on the study, click here/on this link.