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Hemophilia B clinical trials

View clinical trials related to Hemophilia B.

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NCT ID: NCT02250573 Completed - Haemophilia B Clinical Trials

An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery

Start date: December 2005
Phase: Phase 3
Study type: Interventional

The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.

NCT ID: NCT02250560 Completed - Haemophilia B Clinical Trials

A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.

Start date: April 2000
Phase: Phase 3
Study type: Interventional

The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.

NCT ID: NCT02241694 Completed - Clinical trials for Congenital Bleeding Disorder

To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives

HERO
Start date: November 2014
Phase: N/A
Study type: Observational

This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.

NCT ID: NCT02234310 Completed - Hemophilia B Clinical Trials

Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B

PUPs B-LONG
Start date: November 13, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.

NCT ID: NCT02231944 Completed - Haemophilia B Clinical Trials

An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients

Start date: July 1997
Phase: Phase 3
Study type: Interventional

To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study. To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety

NCT ID: NCT02213250 Completed - Hemophilia B Clinical Trials

An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK study and to support the registration in China.

NCT ID: NCT02199717 Completed - Hemophilia A Clinical Trials

An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia

HEPS
Start date: September 2013
Phase: N/A
Study type: Observational [Patient Registry]

This pilot project was developed to investigate subjective and objective data related to the patterns of physical activity participation among hemophilia patients (FVIII or FIX) between the ages of 5 and 18 years. Physical activity participation among different levels of disease severity will be compared using accelerometers to calculate the amount of time spent in moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA; additionally, data will be collected from two validated questionnaires (PedHAL and 3 day physical activity recall). Current literature that relates level of physical activity to disease severity in the pediatric hemophilia population is limited. The information gained about the type and quantity of physical activity participation in children with varying levels of hemophilia will assist in the development of education and interventions to promote good physical activity and potentially examine the role of tailored prophylaxis.

NCT ID: NCT02190149 Completed - Hemophilia A Clinical Trials

Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS

SPACE
Start date: July 22, 2014
Phase:
Study type: Observational

This 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.

NCT ID: NCT02141074 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

paradigmâ„¢6
Start date: July 2, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

NCT ID: NCT02061072 Completed - Hemophilia A Clinical Trials

Web-based Application for the Population Pharmacokinetic Service - Phase 1

WAPPS
Start date: January 2015
Phase:
Study type: Observational [Patient Registry]

The aims of this trials are: 1. to collect published and unpublished individual classic pharmacokinetic data (individual patient data from independent investigators and pharmaceutical companies) 2. to make available population pharmacokinetic models for the concentrates derived from the data collected 3. to develop a web based application intended to use the above models to calculate pharmacokinetic parameters for individual patients, and 4. to test the system functionality via simulation of the use of the prototype by use of faked test data.