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NCT02670213 Clinical Trial

A Study of Safety and Effectiveness of NovoThirteen® (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan

Congenital Bleeding Disorder Clinical Trial

Official title:
A Multicentre, Non-interventional Post Marketing Study of Safety and Effectiveness of NovoThirteenR (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02670213
Other study ID # NN1841-4211
Secondary ID U1111-1162-5426
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 16, 2016
Est. completion date September 30, 2024

Study information
Verified date November 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 8
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• recombinant factor XIII
No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician.

Locations
Country Name City State
Japan Novo Nordisk Investigational Site Aichi
Japan Novo Nordisk Investigational Site Gamagori-shi, Aichi
Japan Novo Nordisk Investigational Site Hiroshima
Japan Novo Nordisk Investigational Site Kure-shi, Hiroshima
Japan Novo Nordisk Investigational Site Muroran, Hokkaido,
Japan Novo Nordisk Investigational Site Saitama
Japan Novo Nordisk Investigational Site Shiga
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect Year 0-9
Secondary All serious adverse events Year 0-9
Secondary All adverse events Year 0-9
Secondary All medical event of special interest Year 0-9
Secondary All medication errors collected Year 0-9
Secondary All technical complaints Year 0-9
Secondary Use of NovoThirteen® for other uses than for the approved indication Year 0-9
Secondary Frequency of bleeding episodes Year 0-9
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