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11 Diseases |  |
2 Trials |
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2 Trials |  |
203 News |  |
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- ||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Clinical: El Dr Bonanad defiende nuestro póster sobre el switch guiado por #farmacocinetica entre Kogenate y Kovaltry #ISTH2019 @WAPPS_Hemo @HospitalLaFe @HematoLaFe (Twitter) - Jul 7, 2019
- ||| Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
New #AusPAR for #Kovaltry [#Octocog alfa (bhk)] for treatment of #Haemophilia A: https://t.co/CYZr8EtlNy (Twitter) - Jul 1, 2019
- | New P4 trial: Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients. Implementatie van farmacokinetisch gestuurd doseren van profylaxe bij hemofilie patienten. (EUDRACT) - Dec 21, 2018
P4, N=50, , Sponsor: Erasmus University Medical Center
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion date, Trial primary completion date, Real-world evidence, Real-world: TAURUS: Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis (clinicaltrials.gov) - Oct 25, 2018
P=N/A, N=350, Recruiting, Sponsor: Bayer
Trial completion date: Jun 2020 --> Jun 2022 | Trial primary completion date: Jan 2020 --> Dec 2021
- ||| Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer
New trial: Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry (clinicaltrials.gov) - Aug 24, 2018
P=N/A, N=128, Recruiting, Sponsor: Bayer
- ||| Kovaltry (octocog alfa) / Bayer, CSL Behring, Jivi (damoctocog alfa pegol) / Bayer
Enrollment open: Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry (clinicaltrials.gov) - Aug 24, 2018
P=N/A, N=128, Recruiting, Sponsor: Bayer
Trial completion date: Jun 2020 --> Jun 2022 | Trial primary completion date: Jan 2020 --> Dec 2021 Not yet recruiting --> Recruiting
- | Kovaltry (octocog alfa) / Bayer, CSL Behring
Review, Journal: BAY 81-8973, a full-length recombinant factor VIII for the treatment of hemophilia A: product review. (Pubmed Central) - Jul 19, 2018
Either the one-stage or the chromogenic assay provides accurate measurements for postinfusion monitoring of BAY 81-8973 levels, with no product-specific calibration standard needed. The incidence of treatment-related adverse events was ⩽7% across all LEOPOLD studies, and no previously treated patient developed anti-BAY 81-8973 inhibitors in the completed primary studies.
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
Phase classification, Real-world evidence, Real-world: TAURUS: Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis (clinicaltrials.gov) - Apr 3, 2018
P, N=350, Recruiting, Sponsor: Bayer
The incidence of treatment-related adverse events was ⩽7% across all LEOPOLD studies, and no previously treated patient developed anti-BAY 81-8973 inhibitors in the completed primary studies. Phase classification: P=N/A --> P
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment change: Drug Use Investigation of Kovaltry in Hemophilia A Patients (clinicaltrials.gov) - Feb 6, 2018
P=N/A, N=30, Recruiting, Sponsor: Bayer
Phase classification: P=N/A --> P N=200 --> 30
- |||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial primary completion date: LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) - Sep 18, 2017
P3, N=101, Recruiting, Sponsor: Bayer
N=200 --> 30 Trial primary completion date: Dec 2019 --> Dec 2022
- || Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial primary completion date, Real-world evidence, Real-world: TAURUS: Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis (clinicaltrials.gov) - Aug 29, 2017
P=N/A, N=350, Recruiting, Sponsor: Bayer
Trial primary completion date: Dec 2019 --> Dec 2022 Trial primary completion date: Jul 2019 --> Jan 2020
- ||||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment change: LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) - Jul 13, 2017
P3, N=101, Recruiting, Sponsor: Bayer
Trial primary completion date: Jul 2019 --> Jan 2020 N=75 --> 101
- | Journal: Baby hamster kidney cell-derived recombinant factor VIII: a quarter century of learning and clinical experience. (Pubmed Central) - May 20, 2017
This review provides a historical overview of rFVIII development with a focus on Bayer's rFVIII (with albumin) and sucrose-formulated rFVIII (rFVIII-FS), the only rFVIII products cloned in baby hamster kidney (BHK) cells with >25 years of proven safety and efficacy...Innovative products with new treatment potentials (eg, BAY 81-8973 and BAY 94-9027) built on this established safety and efficacy profile are also briefly discussed...The net effects have been joint health preservation, reduction in morbidity and mortality, and quality-of-life enhancements. Current treatment challenges include lack of adherence to prophylaxis and inhibitor development; extended-half-life rFVIII products and non-FVIII replacement therapies in development may help overcome these challenges.
- | Kovaltry (octocog alfa) / Bayer, CSL Behring
Phase classification, Real-world evidence, Real-world: TAURUS: Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis (clinicaltrials.gov) - Jan 26, 2017
P=N/A, N=350, Recruiting, Sponsor: Bayer
Current treatment challenges include lack of adherence to prophylaxis and inhibitor development; extended-half-life rFVIII products and non-FVIII replacement therapies in development may help overcome these challenges. Phase classification: P4 --> P=N/A
- ||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment open: Drug Use Investigation of Kovaltry in Hemophilia A Patients (clinicaltrials.gov) - Dec 22, 2016
P=N/A, N=200, Recruiting, Sponsor: Bayer
Phase classification: P4 --> P=N/A Not yet recruiting --> Recruiting
- |||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment open, Real-world evidence, Real-world: TAURUS: Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis (clinicaltrials.gov) - Nov 29, 2016
P4, N=350, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| Kovaltry (octocog alfa) / Bayer, CSL Behring
New trial: Drug Use Investigation of Kovaltry in Hemophilia A Patients (clinicaltrials.gov) - Oct 20, 2016
P=N/A, N=200, Not yet recruiting, Sponsor: Bayer
- ||||| Kovaltry (octocog alfa) / Bayer, CSL Behring
New P4 trial, Real-world evidence, Real-world: TAURUS: Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis (clinicaltrials.gov) - Jul 13, 2016
P4, N=350, Not yet recruiting, Sponsor: Bayer
- |||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial primary completion date: LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) - Mar 7, 2016
P3, N=75, Recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Trial primary completion date: Dec 2017 --> Dec 2019
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion: Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate (clinicaltrials.gov) - Jan 20, 2016
P1, N=8, Completed, Sponsor: Bayer
Trial primary completion date: Dec 2017 --> Dec 2019 Active, not recruiting --> Completed
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment change: Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate (clinicaltrials.gov) - Oct 22, 2015
P1, N=8, Active, not recruiting, Sponsor: Bayer
Active, not recruiting --> Completed N=18 --> 8
- ||| Enrollment open: ATHN 2: Factor Switching Study (clinicaltrials.gov) - Oct 22, 2015
P=N/A, N=600, Recruiting, Sponsor: American Thrombosis and Hemostasis Network
N=18 --> 8 Not yet recruiting --> Recruiting
- ||| New trial: ATHN 2: Factor Switching Study (clinicaltrials.gov) - Sep 14, 2015
P=N/A, N=600, Not yet recruiting, Sponsor: American Thrombosis and Hemostasis Network
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment closed: Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate (clinicaltrials.gov) - Jul 29, 2015
P1, N=18, Active, not recruiting, Sponsor: Bayer
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment open: Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate (clinicaltrials.gov) - Jul 25, 2015
P1, N=18, Recruiting, Sponsor: Bayer
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Kovaltry (octocog alfa) / Bayer, CSL Behring
New P1 trial: Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate (clinicaltrials.gov) - Jun 26, 2015
P1, N=18, Not yet recruiting, Sponsor: Bayer
- ||||||| Abstilla (lonoctocog alfa) / CSL Behring, Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion, Enrollment change: An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A (clinicaltrials.gov) - Jan 12, 2015
P2/3, N=175, Completed, Sponsor: CSL Behring
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | N=104 --> 175
- |||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial primary completion date: LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) - Dec 30, 2014
P3, N=75, Recruiting, Sponsor: Bayer
Active, not recruiting --> Completed | N=104 --> 175 Trial primary completion date: Dec 2016 --> Dec 2017
- ||||| Abstilla (lonoctocog alfa) / CSL Behring, Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment closed: An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A (clinicaltrials.gov) - Nov 19, 2014
P2/3, N=104, Active, not recruiting, Sponsor: CSL Behring
Trial primary completion date: Dec 2016 --> Dec 2017 Recruiting --> Active, not recruiting
- ||||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial initiation date: LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) - Apr 17, 2014
P3, N=75, Recruiting, Sponsor: Bayer
Recruiting --> Active, not recruiting Initiation date: Jun 2011 --> Jun 2011
- ||||||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion: Leopold I: Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A (clinicaltrials.gov) - Apr 15, 2013
P3, N=74, Completed, Sponsor: Bayer
Initiation date: Jun 2011 --> Jun 2011 Active, not recruiting --> Completed
- ||||||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Trial completion, Head-to-Head: Leopold II: A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A (clinicaltrials.gov) - Jan 24, 2013
P3, N=80, Completed, Sponsor: Bayer
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Abstilla (lonoctocog alfa) / CSL Behring, Kovaltry (octocog alfa) / Bayer, CSL Behring
New P2/3 trial: An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A (clinicaltrials.gov) - Dec 5, 2011
P2/3, N=104, Recruiting, Sponsor: CSL Behring
- ||||| Kovaltry (octocog alfa) / Bayer, CSL Behring
Enrollment change, Head-to-Head: Leopold II: A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A (clinicaltrials.gov) - Nov 14, 2011
P3, N=80, Completed, Sponsor: Bayer
Active, not recruiting --> Completed N=66 --> 80