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Completed

NCT Number: NCT02670213

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

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.

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Key information

Conditions

Congenital Bleeding Disorder Congenital FXIII Deficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya University Hospital_Blood Transfusion, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant factor XIII

Drug

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

Primary outcomes

  1. 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

  1. All serious adverse events

    Time frame: Year 0-9

  2. All adverse events

    Time frame: Year 0-9

  3. All medical event of special interest

    Time frame: Year 0-9

  4. All medication errors collected

    Time frame: Year 0-9

  5. All technical complaints

    Time frame: Year 0-9

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

    Time frame: Year 0-9

  7. Frequency of bleeding episodes

    Time frame: Year 0-9

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2016
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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