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Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

NCT ID: NCT01862367

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-17

Study Completion Date

2019-06-26

Brief Summary

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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®.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Congenital FXIII Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rFXIII

catridecacog

Intervention Type DRUG

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

Interventions

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catridecacog

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

Intervention Type DRUG

Other Intervention Names

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recombinant factor XIII

Eligibility Criteria

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Inclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Orange, California, United States

Site Status

Novo Nordisk Investigational Site

Tampa, Florida, United States

Site Status

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Detroit, Michigan, United States

Site Status

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Site Status

Novo Nordisk Investigational Site

Cleveland, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Columbus, Ohio, United States

Site Status

Novo Nordisk Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Debrecen, , Hungary

Site Status

Novo Nordisk Investigational Site

Chieti, , Italy

Site Status

Novo Nordisk Investigational Site

Genova, , Italy

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Málaga, , Spain

Site Status

Novo Nordisk Investigational Site

Tortosa, , Spain

Site Status

Novo Nordisk Investigational Site

Aberdeen, , United Kingdom

Site Status

Countries

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United States Canada Hungary Italy Spain United Kingdom

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1131-1558

Identifier Type: OTHER

Identifier Source: secondary_id

ENCEPP/SDPP/3687

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN1841-3868

Identifier Type: -

Identifier Source: org_study_id

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