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

NCT02670213 | Completed

• 2 other identifiers: NN1841-4211U1111-1162-5426
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 8

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.

Conditions

Congenital Bleeding Disorder; Congenital FXIII Deficiency

Outcome Measures

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

  Year 0-9

Secondary Outcomes (7)

• 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

• All technical complaints

  Year 0-9

Study Arms (1)

NovoThirteen®

Drug: recombinant factor XIII

Interventions

recombinant factor XIII DRUG

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

NovoThirteen®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (8)

Nagoya University Hospital_Blood Transfusion

Aichi, 466-8560, Japan

Location

Gamagori Hospital

Gamagori-shi, Aichi, 443-8501, Japan

Location

Chugoku Central Hospital

Hiroshima, 720-0001, Japan

Location

Kure Medical Center and Chugoku Cancer Center

Kure-shi, Hiroshima, 737-0023, Japan

Location

Nikko Memorial Hospital

Muroran, Hokkaido,, 051-8501, Japan

Location

Saitama Children's Med Centre_Hematology-Oncology

Saitama, 330-8777, Japan

Location

Takashima Municipal Hospital

Shiga, 520-1121, Japan

Location

Ogikubo Hospital_Pediatries & Blood

Tokyo, 167-0035, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Interventions

recombinant factor XIII-A2

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 1, 2016
• Study Start: March 16, 2016
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (8)