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NCT00945906 · ClinicalTrials.gov registry record · Phase 3
An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
A Phase 3 study of Factor XIII Deficiency, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
- 20
- Study locations
NCT00945906: Completed Phase 3 study of Factor XIII Deficiency, sponsored by CSL Behring.
NCT00945906 is a Phase 3 study of Factor XIII Deficiency that has completed, run by CSL Behring. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00945906, a Phase 3 study of Factor XIII Deficiency, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
- 20
- Study locations
Study Summary
Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding. In this study, patients will be treated with FXIII Concentrate (Human) and followed closely to determine that they receive the dose of FXIII Concentrate (Human) that will best minimize the chance of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate (Human) to patients until the product becomes commercially available in the United States.
Primary Outcome
Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment-related AEs are defined as AEs whose relationship to treatment is related, or possibly related and AEs with missing relationship.
Conditions Studied
Interventions
- BIOLOGICAL FXIII Concentrate (Human) (FXIII)
Study Locations (20)
California
- Study Site - Oakland
- Study Site - Orange
- Study Site - San Francisco
- Study Site - Stockton
Florida
- Study Site - Fort Myers
- Study Site - Miami
- Study Site - St. Petersburg
Michigan
- Study Site - Ann Arbor
- Study Site - Detroit
New York
- Study Site - Albany
- Study Site - New York
Alabama
- Study Site - Dothan
Louisiana
- Study Site - New Orleans
Massachusetts
- Study Site - Boston
Missouri
- Study Site - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT00945906 record still lists
NCT00945906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Factor XIII Deficiency appearing as the primary indexed condition, and to 1 intervention - of which FXIII Concentrate (Human) (FXIII) is the first listed.
NCT00945906 names 20 study sites across 13 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT00945906 about?
NCT00945906 is a clinical study titled "An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency". Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby...
What is the current status of trial NCT00945906?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2009-09. Estimated completion is 2011-08.
What conditions does trial NCT00945906 study?
This clinical trial studies the following conditions: Factor XIII Deficiency.
What interventions are being tested in trial NCT00945906?
The interventions under investigation include: FXIII Concentrate (Human) (FXIII) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00945906?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00945906 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00945906's enrollment target sits among peer trials
61 1803rd of 2000 higher than 197 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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