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Coagulation Factor

FXIII for Factor XIII Deficiency

Phase 2
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Factor XIII Deficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incremental Recovery
Secondary study objectives
Adverse Events
Laboratory Safety Parameters
Vital Signs

Side effects data

From 2011 Phase 3 trial • 41 Patients • NCT00885742
24%
Upper respiratory infection
12%
Fever
12%
Cough
10%
Fall
10%
Nasal congestion
7%
Vomiting
7%
Abrasions
7%
Bruising of thigh
7%
Sore throat
7%
Acne
7%
Thrombin-antithrombin III complex increased
7%
Wrist pain
7%
Headache
7%
Rhinorrhea
2%
Urinary tract infection
2%
Appendicitis
2%
Traumatic chest injury NOS
2%
Chest pain with radiation to left arm
2%
Hip injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
FXIII

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FXIIIExperimental Treatment1 Intervention
All subjects treated with Factor XIII Concentrate (Human) (FXIII)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FXIII Concentrate (Human)
2009
Completed Phase 3
~60

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
198 Previous Clinical Trials
1,204,806 Total Patients Enrolled
3 Trials studying Factor XIII Deficiency
174 Patients Enrolled for Factor XIII Deficiency
Program Director, Clinical R&DStudy DirectorCSL Behring
12 Previous Clinical Trials
874 Total Patients Enrolled
2 Trials studying Factor XIII Deficiency
102 Patients Enrolled for Factor XIII Deficiency
~1 spots leftby Nov 2025
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