Drugs / CSL689
last change Mar 2018 re-read 2 minutes ago

CSL689

also known as rVIIa-FP

Protein / enzyme biologic

Developed for
congenital factor VII deficiency · hemophilia A · hemophilia B
Investigated by
CSL Behring

Trials 2 · a red edge is where a trial was stopped

201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02470871 Jul 2015 → Jul 2016 congenital factor VII deficiency CSL Behring Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02484638 Jul 2015 → Mar 2018 hemophilia A, hemophilia B CSL Behring Terminated No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2013-07-03 CSL Behring CSL Behring Presents Phase I Results From Study of Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP) in Healthy Volunteers csl.com
2012-03-29 CSL Behring CSL Behring Commences Phase I study with rVIIa-FP, a Novel Therapy to Treat People With Hemophilia A and Hemophilia B Who Have Inhibitors csl.com
2012-02-16 CSL Behring CSL Behring Receives FDA Orphan Drug Designation for rVIIa-FP, a Novel Therapy in Development to Treat Hemophilia A and Hemophilia B Patients Who Have Inhibitors csl.com
2011-05-31 CSL Behring CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment csl.com

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as CSL689 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02470871
1

NCT02484638

Known as rVIIa-FP “Experimental Drug: Recombinant fusion protein, linking activated FVII with albumin (rVIIa-FP). Subjects will receive a single dose of CSL689 at either a low dose (Arm 1) or a...” NCT02470871
1

“The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety of rVIIa-FP (CSL689).” NCT02484638

Modality Protein / enzyme biologic “Recombinant fusion protein, linking activated FVII with albumin (rVIIa-FP)” NCT02470871
Route Other “CSL689 injection” NCT02470871