Brief Summary

This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect. The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach

6 countries

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.1 years study duration

Study Start

First participant enrolled

May 17, 2013

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed

6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed

Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

6.1 years

First QC Date

May 21, 2013

Last Update Submit

July 8, 2019

Conditions

Congenital Bleeding Disorder Congenital FXIII Deficiency

Outcome Measures

Primary Outcomes (1)

Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with rFXIII,comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of effect collected
During study period up to 6 years

Secondary Outcomes (5)

All serious adverse events collected
During study period up to 6 years
All medical events of special interest collected
During study period up to 6 years
All medication errors and near medication errors collected
During study period up to 6 years
Use of rFXIII in patients with congenital FXIII A-subunit deficiency also for other uses than for prophylactic treatment collected
During study period up to 6 years
Frequency of bleeding episodes collected
During study period up to 6 years

Study Arms (1)

rFXIII

Drug: catridecacog

Interventions

catridecacogDRUG

No treatment given. All patients enrolled in this observational study will receive their medication through usual commercial channels.

Also known as: recombinant factor XIII

rFXIII

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

This observational study will enroll patients with congenital FXIII A-subunit deficiency for whom the decision to treat with rFXIII has been made and who are willing to provide informed consent (or patient's legally acceptable representative (LAR) consent, if applicable).

You may qualify if:

Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
Able and willing to provide signed informed consent (or patient's legally acceptable representative (LAR) consent, if applicable), as required by local ethics committee, governmental or regulatory authorities
Congenital FXIII A-subunit deficiency
Actual or planned exposure to rFXIII

Contact the study team to confirm eligibility.