BAX 326 (rFIX) Continuation Study
This study is currently recruiting participants.
Verified March 2013 by Baxter Healthcare Corporation
Sponsor:
Baxter Healthcare Corporation
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01286779
First received: January 26, 2011
Last updated: March 20, 2013
Last verified: March 2013
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Purpose
The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemophilia B |
Biological: BAX 326 (Recombinant factor IX) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | BAX 326 (Recombinant Factor IX): Evaluation of Safety, Immunogenicity, and Hemostatic Efficacy in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level <= 2%) Hemophilia B - A Continuation Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
Drug Information available for:
Factor IX
U.S. FDA Resources
Further study details as provided by Baxter Healthcare Corporation:
Primary Outcome Measures:
- Adverse events possibly or probably related to the investigational product [ Time Frame: Assessed (based on patient diary) every 3 months until study completion ] [ Designated as safety issue: Yes ]Descriptive analysis
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BAX 326 |
Biological: BAX 326 (Recombinant factor IX)
The treatment with BAX 326 will be at the discretion of the investigator and will consist of either twice weekly prophylactic treatment with 50 IU/kg, modified prophylaxis, or on-demand treatment.
|
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Main Inclusion Criteria:
- Subject and/or legal representative has/have voluntarily provided signed informed consent
- Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical study 251101 (pediatric study)
- Subject was 12 to 65 years old at the time of screening for Study 250901 or < 12 years old at the time of screening for Study 251101
- Subject has severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested at screening at the central laboratory
- Subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study 250901 or Pediatric Study 251101
Main Exclusion Criteria:
- Subject received factor IX product(s) other than BAX 326 upon completion of Baxter Pivotal Study 250901 or Pediatric Study 251101
- Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B
- For subjects transferring from Pivotal Study 250901: Subject's weight is < 35 kg or > 120 kg
- Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the Continuation Study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286779
Show 26 Study Locations
Contacts
| Contact: Susanne Schmiedl, Clinical Project Manager | susanne_schmiedl@baxter.com |
Show 26 Study LocationsSponsors and Collaborators
Baxter Healthcare Corporation
Baxter Innovations GmbH
Investigators
| Study Director: | Brigitt Abbuehl, MD | Baxter Innovations GmbH |
More Information
No publications provided
| Responsible Party: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT01286779 History of Changes |
| Other Study ID Numbers: | 251001, 2010-022726-33 |
| Study First Received: | January 26, 2011 |
| Last Updated: | March 20, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: Agencia Nacional de Vigilance Sanitaria (ANVISA) Bulgaria: Bulgarian Drug Agency Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Germany: Paul-Ehrlich-Institut India: Drugs Controller General of India Japan: Pharmaceuticals and Medical Devices Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: FSI Scientific Center of Expertise of Medical Application Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hemophilia B Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked |
ClinicalTrials.gov processed this record on May 23, 2013