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Congenital Bleeding Disorder clinical trials

View clinical trials related to Congenital Bleeding Disorder.

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NCT ID: NCT00922792 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B

Start date: June 2009
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.

NCT ID: NCT00882778 Completed - Clinical trials for Congenital Bleeding Disorder

PROPACT: Retrospective Prophylaxis Patient Case Collection

PROPACT
Start date: April 2009
Phase: N/A
Study type: Observational

This study is conducted in Europe and North and South America. The primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment with activated recombinant human factor VII. The secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of activated recombinant human factor VII when used as prevention. The study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.

NCT ID: NCT00853086 Completed - Clinical trials for Congenital Bleeding Disorder

Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database

Start date: January 2008
Phase: N/A
Study type: Observational

This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.

NCT ID: NCT00840086 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

guardian™1
Start date: April 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

NCT ID: NCT00837356 Completed - Clinical trials for Congenital Bleeding Disorder

Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

Start date: March 2009
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.

NCT ID: NCT00822185 Completed - Healthy Clinical Trials

Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

Start date: January 2009
Phase: Phase 1
Study type: Interventional

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined

NCT ID: NCT00713648 Completed - Clinical trials for Congenital Bleeding Disorder

Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.

NCT ID: NCT00710619 Completed - Clinical trials for Congenital Bleeding Disorder

Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX

DOSE
Start date: June 2008
Phase: N/A
Study type: Observational

This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.

NCT ID: NCT00703911 Completed - Clinical trials for Congenital Bleeding Disorder

Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

ONE
Start date: March 2008
Phase: N/A
Study type: Observational

This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant human factor VII and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

NCT ID: NCT00697320 Completed - Clinical trials for Congenital Bleeding Disorder

Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany

WIRK
Start date: June 2008
Phase: N/A
Study type: Observational

This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.