Clinical Trials Logo

Clinical Trial Summary

Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate.

Following informed consent and eligibility, historical patient information including demographics, allergy history, hemophilia history, frequency and severity of allergic reaction(s), number of exposure days with products causing allergic reactions, exposure days to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of event(s), any other adverse event(s) occuring within 48 hours of onset of allergic reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and outcome, current status of patient, and results of any special studies (eg, skin or RAST testing, alloantibody analyses, ect) will be collected.


Clinical Trial Description

n/a


Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT00195221
Study type Observational
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 4
Start date February 2005
Completion date November 2007

See also
  Status Clinical Trial Phase
Completed NCT04072237 - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia Phase 1
Completed NCT02199717 - An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia N/A
Completed NCT01662531 - A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B Phase 3
Completed NCT01335061 - Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B Phase 3
Completed NCT01217255 - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed NCT00037557 - Study Evaluating rFIX; BeneFIX in Severe Hemophilia B Phase 3
Completed NCT02554773 - An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B Phase 1/Phase 2
Terminated NCT02807753 - The Hemophilia Ultrasound Project
Active, not recruiting NCT03901755 - An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
Not yet recruiting NCT05980377 - Patterns of Hemophilia Care in Assiut Children Patients
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Terminated NCT03248141 - Understanding Hemophilia A and B Drug Dosage Administration Patterns
Terminated NCT01460147 - Osteoporosis and MRI Study in Hemophilia N/A
Completed NCT03818529 - ATHN 8: Previously Untreated Patients (PUPs) Matter Study
Completed NCT02571569 - A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors Phase 1
Terminated NCT01620801 - Hemophilia B Gene Therapy With AAV8 Vector Phase 1
Completed NCT01233440 - Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B Phase 1
Active, not recruiting NCT04135300 - Gene Therapy for Chinese Hemophilia B N/A
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Terminated NCT00947193 - Study of Ataluren (PTC124) in Hemophilia A and B Phase 2