Drugs / Factor VIII
Trials 2 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT00404300 | Feb 2007 → Sep 2008 | von Willebrand disease (hereditary or acquired) | Bio Products Laboratory | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02697370 | Apr 2013 → May 2015 | severe hemophilia A | Hampshire Hospitals NHS Foundation Trust | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06938659 Comparator | Jun 2025 → May 2026 overdue | hemophilia A | Dhaka Medical College | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02847637 Background | Sep 2016 → Sep 2017 | hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01561391 Background | Apr 1998 → May 2004 | congenital hematological disorder, hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
Press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-03-14 | Roche Global Development | European Commission approves Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors roche.com ↗ |
| 2019-02-01 | Roche Global Development | CHMP recommends EU approval of Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors roche.com ↗ |
| 2018-08-30 | Roche Global Development | Positive phase III results for Roche's Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine roche.com ↗ |
| 2018-06-05 | Roche Global Development | FDA grants Priority Review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors roche.com ↗ |
| 2018-05-21 | Roche Global Development | Roche’s Hemlibra reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in haemophilia A without factor VIII inhibitors roche.com ↗ |
| 2018-02-27 | Novo Nordisk A/S | Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A novonordisk.com ↗ |
| 2014-03-19 | Novo Nordisk A/S | Positive results from first phase 3 trial with N8-GP, a long-acting factor VIII for treatment of haemophilia A novonordisk.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Factor VIII | “The patient's current factor VIII product will be used.” NCT02697370 ↗ |
| Known as | FVIII | “Factor VIII (FVIII)” NCT06938659 ↗1“Factor VIII (FVIII)” NCT02847637 ↗ |
| Action | Restore | “Factor VIII replacement therapy - non brand specific” NCT02697370 ↗ |
| Modality | Protein / enzyme biologic | “factor VIII concentrate” NCT02697370 ↗ |