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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00640289
Date of registration: 17/03/2008
Prospective Registration: No
Primary sponsor: Children's Hospital of Orange County
Public title: Clinical Trial of Factor XIII (FXIII) Concentrate
Scientific title: Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency
Date of first enrolment: January 2000
Target sample size: 72
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00640289
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Diane J. Nugent, MD
Address: 
Telephone:
Email:
Affiliation:  Children's Hospital of Orange Co.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients may be of either sex or age. Children and newborn infants are specifically
included in this study.

- Patient must have documented congenital Factor XIII deficiency

- Patient or legal guardian must sign informed consent

- Patients who have negative serology for hepatitis B should receive Hepatitis B
vaccination.

Exclusion Criteria:

- Patient has acquired Factor XIII deficiency



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Hemophilia
Factor XIII Deficiency
Intervention(s)
Drug: Fibrogammin P
Primary Outcome(s)
Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions [Time Frame: Within 12 hours of FXIII infusion]
Secondary Outcome(s)
Surgical Efficacy Assessments With Factor XIII [Time Frame: During surgical procedure]
Secondary ID(s)
BB-IND5986
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
CSL Behring
Ethics review
Results
Results available: Yes
Date Posted: 07/11/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00640289
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