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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-16

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

NCT01862367

Congenital Bleeding Disorder Congenital FXIII Deficiency

COMPLETED

Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency

NCT01230021

Congenital Bleeding Disorder Congenital FXIII Deficiency

COMPLETED PHASE3

Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725

NCT00978380

Congenital Bleeding Disorder Congenital FXIII Deficiency

COMPLETED PHASE3

Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

NCT00056589

Congenital Bleeding Disorder Congenital FXIII Deficiency

COMPLETED PHASE1

Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency

NCT01253811

Congenital Bleeding Disorder Congenital FXIII Deficiency

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Bleeding Disorder Congenital FXIII Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NovoThirteen®

recombinant factor XIII

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

recombinant factor XIII

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No