CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
FXIII Concentrate (Human)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00883090
NCT00883090Phase 2Completed
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A 12 Week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

CSL Behring·interventional·Posted Apr 17, 2009·Updated Jan 16, 2012

In Brief

A Phase 2 clinical trial evaluating FXIII Concentrate (Human) for Factor XIII Deficiency. Completed, enrolled 15 participants across 6 sites in 2 countries.

Detailed Summary

Congenital deficiency of Factor XIII is an extremely rare hereditary disorder associated with potentially life-threatening bleeding. This study will evaluate the safety and recommended (best) amount or level of Factor XIII in a patient's blood. Factor XIII Concentrate (Human) is given to people whose blood is lacking Factor XIII. Factor XIII Concentrate (Human) works by assisting your blood in the usual clotting process, thereby preventing bleeding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFactor XIII Deficiency
CountriesSpain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2009
Enrollment StartMay 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.2 years ago

Interventions

FXIII Concentrate (Human)biological

Subjects will receive approximately 40 U/kg of FXIII every 28 days for 3 doses administered as a bolus intravenous (IV) injection at approximately 250 U/minute.