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mentor™6: Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01862367
Collaborator
(none)
30
Enrollment
17
Locations
73.3
Actual Duration (Months)
1.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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®.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study
Actual Study Start Date :
May 17, 2013
Actual Primary Completion Date :
Jun 26, 2019
Actual Study Completion Date :
Jun 26, 2019

Arms and Interventions

Arm Intervention/Treatment
rFXIII

Drug: catridecacog
No treatment given. All patients enrolled in this observational study will receive their medication through usual commercial channels.
Other Names:
  • recombinant factor XIII

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. All serious adverse events collected [During study period up to 6 years]

    2. All medical events of special interest collected [During study period up to 6 years]

    3. All medication errors and near medication errors collected [During study period up to 6 years]

    4. 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]

    5. Frequency of bleeding episodes collected [During study period up to 6 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Orange California United States 92868
    2 Novo Nordisk Investigational Site Tampa Florida United States 33607
    3 Novo Nordisk Investigational Site Atlanta Georgia United States 30322
    4 Novo Nordisk Investigational Site Detroit Michigan United States 48201
    5 Novo Nordisk Investigational Site Minneapolis Minnesota United States 55404
    6 Novo Nordisk Investigational Site Cleveland Ohio United States 44106
    7 Novo Nordisk Investigational Site Columbus Ohio United States 43205
    8 Novo Nordisk Investigational Site St. John's Newfoundland and Labrador Canada A1B 3V6
    9 Novo Nordisk Investigational Site Toronto Ontario Canada M5G 1X8
    10 Novo Nordisk Investigational Site Debrecen Hungary 4012
    11 Novo Nordisk Investigational Site Chieti Italy 66100
    12 Novo Nordisk Investigational Site Genova Italy 16147
    13 Novo Nordisk Investigational Site Barcelona Spain 08035
    14 Novo Nordisk Investigational Site Madrid Spain 28046
    15 Novo Nordisk Investigational Site Málaga Spain 29011
    16 Novo Nordisk Investigational Site Tortosa Spain 43500
    17 Novo Nordisk Investigational Site Aberdeen United Kingdom AB25 2ZN

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT01862367
    Other Study ID Numbers:
    • NN1841-3868
    • U1111-1131-1558
    • ENCEPP/SDPP/3687
    First Posted:
    May 24, 2013
    Last Update Posted:
    Jul 9, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Hemostatic Disorders
    Blood Coagulation Disorders

    Study Results

    No Results Posted as of Jul 9, 2019