Drugs / rVIIa-FP
rVIIa-FP
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01542619 | Mar → Jun 2012 | — | CSL Behring | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2013-07-03 | CSL Behring | Results 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 ↗
03 Jul 2013 CSL Behring today presented Phase I data of their recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. |
| 2012-02-16 | CSL Behring | Regulatory 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 ↗
CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). |
| 2011-05-31 | CSL Behring | Regulatory CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment csl.com ↗
The designations would entitle CSL Behring to exclusively market recombinant factor VIIa fused with albumin in Europe for a period of 10 years if the product at the stage of license application fulfils the orphan drug requirements. |
All press releases naming this drug 4 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rVIIa-FP | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01542619 ↗ |
| Known as | CSL689 | “A Randomized, Placebo-controlled, Single Center, 5 Cohort Dose Escalation Trial to Investigate Safety and Pharmacokinetics of rVIIa-FP (CSL689) in Comparison to Placebo in...” NCT01542619 ↗ |
| Known as | Recombinant VIIa-FP | “Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin” NCT01542619 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin” NCT01542619 ↗ |
| Route | Intravenous | “will be administered by intravenous infusion” NCT01542619 ↗ |