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Clinical Trial of Factor XIII (FXIII) Concentrate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00640289
First Posted: March 21, 2008
Last Update Posted: February 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Diane J. Nugent, MD, Children's Hospital of Orange County
  Purpose
Congenital deficiency of Factor XIII is a rare but potentially life threatening disorder. It is inherited in an autosomal recessive fashion. Infusion of Factor XIII has proved to be useful for prevention and treatment of bleeding episodes, especially of spontaneous intracranial bleedings. In this study, Fibrogammin P will be given to patients with congenital Factor XIII deficiency and congenital/acquired FXIII deficiency to prevent bleeding and to treat established bleeding episodes. For Factor XIII prophylaxis to prevent hemorrhages, the dosage will depend on the weight of the subject. The frequency of Factor XIII administration will be determined by the factor's circulating half-life. During the first month only, a Factor XIII pharmacokinetic study will be determined over a 4-week period. Safety data will include accrual of information on viral safety, liver function, complete blood counts and adverse events. Historical data concerning spontaneous bleeds will be collected whenever possible two years prior to treatment with Fibrogammin P.

Condition Intervention
Hemophilia Factor XIII Deficiency Drug: Fibrogammin P

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency

Resource links provided by NLM:


Further study details as provided by Diane J. Nugent, MD, Children's Hospital of Orange County:

Primary Outcome Measures:
  • Response to treatment. Active bleeding is controlled. [ Time Frame: Within 12 hours ]

Secondary Outcome Measures:
  • Minimal to no bleeding with surgery following prophylactic treatment. [ Time Frame: During surgery. ]

Enrollment: 73
Study Start Date: January 2000
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Treatment
Drug: Fibrogammin P
Prophylaxis treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640289


Locations
United States, California
Children's Hospital of Orange Co.
Orange, California, United States, 92868
Sponsors and Collaborators
Children’s Hospital of Orange County
CSL Behring
Investigators
Principal Investigator: Diane J. Nugent, MD Children's Hospital of Orange Co.
  More Information

Responsible Party: Diane J. Nugent, MD, Director Hemostasis/Thrombosis Research, Children's Hospital of Orange County
ClinicalTrials.gov Identifier: NCT00640289     History of Changes
Other Study ID Numbers: BB-IND5986
First Submitted: March 17, 2008
First Posted: March 21, 2008
Last Update Posted: February 11, 2015
Last Verified: March 2008

Keywords provided by Diane J. Nugent, MD, Children's Hospital of Orange County:
Factor XIII Deficiency
Rare Bleeding Disorder
Hemophilia
Fibrogammin P

Additional relevant MeSH terms:
Hemophilia A
Factor XIII Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Fibrinolysin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action