Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects

Clinical Trial Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

See also
Status	Clinical Trial	Phase
Completed	`NCT02568202` - Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)	N/A
Completed	`NCT01949792` - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors	Phase 1
Completed	`NCT01205724` - Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A	Phase 1
Completed	`NCT01562587` - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State	Phase 1
Completed	`NCT00108797` - Trial of NovoSeven® in Haemophilia - Joint Bleeds	Phase 4
Completed	`NCT01493778` - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A	Phase 3
Completed	`NCT02490787` - Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects	Phase 1
Completed	`NCT00951405` - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors	Phase 2
Completed	`NCT01876745` - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan	N/A
Completed	`NCT02920398` - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A	Phase 1
Completed	`NCT00984126` - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015	Phase 3
Completed	`NCT01228669` - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B	Phase 1
Completed	`NCT01988532` - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia	N/A
Completed	`NCT01234545` - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors	N/A
Completed	`NCT01779921` - Treatment of Congenital Factor VII Deficiency	N/A
Completed	`NCT01563471` - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers	Phase 1
Completed	`NCT02941354` - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A	Phase 1
Completed	`NCT02241694` - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives	N/A
Completed	`NCT01230021` - Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency	Phase 3
Completed	`NCT01220141` - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B	N/A

NCT number	NCT00978380
Study type	Interventional
Source	Novo Nordisk A/S
Contact
Status	Completed
Phase	Phase 3
Start date	September 21, 2009
Completion date	October 20, 2015

Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 — mentor™2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms