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Hemostatic Disorders clinical trials

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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: NCT00914589 Completed - Clinical trials for Acquired Bleeding Disorder

Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

Start date: July 2009
Phase: Phase 2
Study type: Interventional

This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.

NCT ID: NCT00904709 Completed - Menorrhagia Clinical Trials

The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders

Start date: October 19, 2009
Phase: Phase 4
Study type: Interventional

Many women have heavy periods and this can be associated with low blood, tiredness and inability to carry out normal activities. Approximately 10-30% of these women will have an underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects and they are more common at higher doses. In the medical literature, there are different dosing schedules and there is one commonly recommended in Canada. Women with underlying bleeding disorders may require higher doses of this medication compared to those who do not. In this study, the investigators want to find the lowest effective dose of tranexamic acid for girls and women with heavy periods who have bleeding disorders and the investigators think this will be lower then the usual recommended dose. If the investigators' results support this, it may contribute to changing how the investigators presently prescribe this medication and may provide a better option for women with heavy periods in particular those with bleeding disorders. The investigators have just started a Women with Bleeding Disorders Clinic and hope that this project will lead to better care for the patients and more research in the future.

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: NCT00868309 Completed - Clinical trials for Blood Coagulation Disorders

A Comparison of Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab, Ovine Antivenom (CroFab) in the Treatment of Pit Viper Envenomation

Start date: January 2005
Phase: Phase 2
Study type: Interventional

This phase II study was a prospective, randomized, open-label, multi-center study in the United States, involving patients from 18 to 70 years of age, comparing Anavip (Antivenin Crotalinae [pit viper] equine immune F(ab)2; Instituto Bioclon, Mexico City, Mexico) against CroFab (Protherics Inc., Nashville, Tennessee), the only currently approved product for treatment of Crotalinae (pit viper) envenomation in the US. The study was designed to evaluate the hypothesis that lasting correction of snakebite induced thrombocytopenia and hypofibrinogenemia are possible following correction with F(ab)2 antivenom, by analyzing in detail the relationships among platelet count, fibrinogen, venom levels, and antivenom levels in subjects presenting with thrombocytopenia following crotaline viper envenomation. In the study we expected to see a fall in platelet count following Fab treatment, commensurate with that reported in the past. We hypothesized that following F(ab)2 treatment there would be a slower drop in post-treatment platelet counts, with a relatively higher platelet count at any given point in the follow-up period. We further hypothesized that an initial rise and later fall in platelet count would correspond with rise and fall in antivenom levels, and would be mirrored by concurrent drop and rise in levels of unbound circulating venom.

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: NCT00816127 Completed - Liver Cirrhosis Clinical Trials

Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction

Start date: October 2003
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate how effective and cost saving 1-deamino-8-D-arginine vasopressin (desmopressin, DDAVP) is as opposed to the transfusion of blood products in preventing bleeding after teeth extraction in persons with severe liver disease being evaluated for liver transplant.