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
NCT number | NCT00161720 |
Other study ID # | 400501 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2005 |
Est. completion date | December 1, 2005 |
Verified date | April 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Baxalta now part of Shire |
United States,
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) |
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