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NCT00640289 · ClinicalTrials.gov registry record · NA
Clinical Trial of Factor XIII (FXIII) Concentrate
A NA study of Hemophilia and Factor XIII Deficiency, sponsored by Children's Hospital of Orange County.
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT00640289 is a NA study of Hemophilia and Factor XIII Deficiency that has completed, run by Children's Hospital of Orange County. The registered enrollment target is 72 participants, below the 402-participant average among 9 other Hemophilia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00640289, a NA study of Hemophilia and Factor XIII Deficiency, has completed, sponsored by Children's Hospital of Orange County.
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Fibrogammin P
Study Locations (1)
California
- Children's Hospital of Orange Co. - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2000-01 |
| Est. Completion | 2011-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00640289
The ClinicalTrials.gov registry entry for NCT00640289 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 402-participant average among 9 other Hemophilia trials with a reported enrollment target (82% lower). The listed sponsor is Children's Hospital of Orange County, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hemophilia appearing as the primary indexed condition, and to 1 intervention - of which Fibrogammin P is the first listed.
NCT00640289 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00640289 about?
NCT00640289 is a clinical study titled "Clinical Trial of Factor XIII (FXIII) Concentrate". 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 st...
What is the current status of trial NCT00640289?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2000-01. Estimated completion is 2011-12.
What conditions does trial NCT00640289 study?
This clinical trial studies the following conditions: Hemophilia, Factor XIII Deficiency.
What interventions are being tested in trial NCT00640289?
The interventions under investigation include: Fibrogammin P (DRUG).
Who is sponsoring clinical trial NCT00640289?
This trial is sponsored by Children's Hospital of Orange County, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00640289 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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