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

Novo Nordisk A/S8 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Bleeding Disorder Congenital FXIII Deficiency

Interventions

recombinant factor XIIIDRUG

No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (8)

Nagoya University Hospital_Blood Transfusion

Aichi, Japan

Gamagori Hospital

Gamagori-shi, Aichi, Japan

Chugoku Central Hospital

Hiroshima, Japan

Kure Medical Center and Chugoku Cancer Center

Kure-shi, Hiroshima, Japan

Outcomes

Primary Outcomes

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

Time frame: Year 0-9

Secondary Outcomes

All serious adverse events

Time frame: Year 0-9

All adverse events

Time frame: Year 0-9

All medical event of special interest

Time frame: Year 0-9

All medication errors collected

Time frame: Year 0-9

All technical complaints

Time frame: Year 0-9

Use of NovoThirteen® for other uses than for the approved indication

Time frame: Year 0-9

Frequency of bleeding episodes

Time frame: Year 0-9

Data from ClinicalTrials.gov

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