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

• Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency
• Interventions: Drug: recombinant factor XIII

• Registration Number: NCT02670213
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-01
• Study Start: 2016-03-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 8

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NovoThirteen®	recombinant factor XIII	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All technical complaints	Year 0-9
Frequency of bleeding episodes	Year 0-9
All serious adverse events	Year 0-9
All adverse events	Year 0-9
All medical event of special interest	Year 0-9
All medication errors collected	Year 0-9
Use of NovoThirteen® for other uses than for the approved indication	Year 0-9

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan