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

August 28, 2025 updated by: Novo Nordisk A/S

A Multicentre, Non-interventional Post Marketing Study of Safety and Effectiveness of NovoThirteenR (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, 466-8560
        • Nagoya University Hospital_Blood Transfusion
      • Gamagori-shi, Aichi, Japan, 443-8501
        • Gamagori Hospital
      • Hiroshima, Japan, 720-0001
        • Chugoku Central Hospital
      • Kure-shi, Hiroshima, Japan, 737-0023
        • Kure Medical Center and Chugoku Cancer Center
      • Muroran, Hokkaido,, Japan, 051-8501
        • Nikko Memorial Hospital
      • Saitama, Japan, 330-8777
        • Saitama Children's Med Centre_Hematology-Oncology
      • Shiga, Japan, 520-1121
        • Takashima Municipal Hospital
      • Tokyo, Japan, 167-0035
        • Ogikubo Hospital_Pediatries & Blood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male or female patients, regardless of age, requiring treatment with NovoThirteenR at the discretion of the treating physician

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NovoThirteen®
Drug: recombinant factor XIII
No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Year 0-9

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2016

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimated)

February 1, 2016

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1841-4211
  • U1111-1162-5426 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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