BAY 866150
/ Bayer
- LARVOL DELTA
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December 30, 2014
A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150
(clinicaltrials.gov)
- P2/3; N=10; Terminated; Sponsor: Bayer; Completed -> Terminated
Trial termination • Biosimilar • Hematological Malignancies • Hemophilia
June 11, 2014
Predicting dosing advantages of factor VIIa variants with altered tissue factor and lipid-dependent activities
(J Thromb Haemost)
- "The PK/PD simulations agreed with published ex vivo TG data for rFVIIa and BAY 86-6150 variant and explained the similar efficacy of a single dose of 270 μg/kg (as reported in the literature) and repeated doses of 90 μg/kg of unmodified rFVIIa. The duration of the simulated hemostatic effect after a single optimal dose was prolonged in rFVIIa variants with increased TF affinity or extended half-life, but not for those with modulated PL activity."
PK/PD data • Hemophilia
June 12, 2012
New York Management Meet
(Bayer)
- Anticipated initiation of P2/P3 study for hemophilia in 2012
Anticipated P2/3 trial initiation • Hemophilia
May 03, 2013
Bayer provides update on phase II/III trial of BAY 86-6150
(Bayer)
- "Bayer...announced that a Phase II/III trial evaluating the efficacy and safety of BAY 86-6150 in people with hemophilia A and hemophilia B with inhibitors has been discontinued. Due to safety concerns, we are discontinuing the BAY 86-6150 trial as a precautionary measure."
Trial termination • Hemophilia
May 07, 2012
Deutsche Bank Healthcare Conference
(Bayer)
- Anticipated initiation of combined P2/3 trial for hemophilia in 2012
Anticipated trial initiation date • Hemophilia
June 20, 2012
A phase 2/ 3 trial to evaluate the efficacy and safety of BAY86-6150
(clinicaltrials.gov)
- P2/3, N=65; Not yet recruiting; New P2/3 trial
New P2/3 trial • Pipeline shift • Hemophilia
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