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Completed Phase 3 Interventional Results available

An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

ClinicalTrials.gov ID: NCT00945906

Public ClinicalTrials.gov record NCT00945906. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00945906
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
CSL Behring
Industry
Enrollment
61 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2009 (Type not available)
Primary completion
Aug 2011 (Actual)
Completion
Aug 2011 (Actual)
Last update posted
Oct 12, 2012

2009 – 2011

United States locations

U.S. sites
25
U.S. states
17
U.S. cities
25
Facility City State ZIP Site status
Study Site Dothan Alabama 36301 —
Study Site Oakland California 94609 —
Study Site Orange California 92868 —
Study Site San Francisco California 94118 —
Study Site Stockton California 95204 —
Study Site Fort Myers Florida 33908 —
Study Site Miami Florida 33136 —
Study Site St. Petersburg Florida 33701 —
Study Site New Orleans Louisiana 70121 —
Study Site Boston Massachusetts 02115 —
Study Site Ann Arbor Michigan 48109 —
Study Site Detroit Michigan 48201 —
Study Site Kansas City Missouri 64108 —
Study Site Las Vegas Nevada 89109 —
Study Site Lebanon New Hampshire 03756 —
Study Site Albany New York 12208 —
Study Site New York New York 10065 —
Study Site Chapel Hill North Carolina 27599 —
Study Site Columbus Ohio 43205 —
Study Site Hershey Pennsylvania 17033 —
Study Site Sioux Falls South Dakota 57105 —
Study Site Nashville Tennessee 37232 —
Study Site Dallas Texas 75390 —
Study Site Houston Texas 77030 —
Study site Milwaukee Wisconsin 53223 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00945906, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 12, 2012 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00945906 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →