Drugs / Moroctocog alfa
Moroctocog alfa
also known as
AF-CC · Xyntha · ReFacto · BDDrFVIII · ReFacto AF · Moroctocog alfa(AF-CC) · B-Domain Deleted Recombinant Factor VIII · B-domain Deleted Recombinant Human Factor VIII · +2 more
Protein / enzyme biologic targets F8
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | ReFacto AF | — | 1999-04-13 | europa.eu ↗ |
Trials 18 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04060836 | May 2019 → Mar 2020 | hemophilia A | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02888223 | Sep 2016 → Feb 2017 | hemophilia A | Sinocelltech Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02461992 | Jul → Aug 2015 | hemophilia A | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01579903 | Aug 2012 → Jan 2013 | hemophilia A | Pfizer | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT00759655 | Jun → Dec 2009 | hemophilia A | Wyeth is now a wholly owned subsidiary of Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00868530 | Sep 2008 → Dec 2009 | hemophilia A | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00543439 | Dec 2007 → Apr 2018 | hemophilia A | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00243659 | Apr 2006 → Jun 2008 | hemophilia A | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00038935 | ? → Feb 2003 | hemophilia A | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00037544 | ? → Aug 2004 | hemophilia A | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT04396639 | Jan → Sep 2020 | hemophilia A | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT02492984 | Apr 2015 → Jul 2016 | hemophilia A | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00914459 | Dec 2009 → Mar 2016 | hemophilia A | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00884390 | May 2009 → Mar 2013 | hemophilia A | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT00765726 | Feb 2009 → Jul 2011 | hemophilia A | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT00168051 | Apr → Nov 2005 | hemophilia A | Wyeth is now a wholly owned subsidiary of Pfizer | Withdrawn | No outcome recorded |
| Phase 4 | NCT00092976 | Feb 2003 → Jul 2007 | hemophilia A | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00279578 | Jan → Jun 2006 | hemophilia A | University of Aarhus | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT01051544 Comparator | Sep 2009 → Jun 2020 | severe hemophilia A | City of Hope Medical Center | Withdrawn | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Moroctocog Alfa | “A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery...” NCT00092976 ↗7“Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF-CC) in Subjects With Severe Hemophilia A.” PMID 29575770 ↗ Mar 2018 |
| Known as | AF-CC | “Moroctocog-alfa (AF-CC) is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital...” NCT04396639 ↗6“This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC)) in male patients less than 6 years old.” NCT00759655 ↗ “Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF-CC) in Subjects With Severe Hemophilia A.” PMID 29575770 ↗ Mar 2018 “Providing moroctocog alfa (AF-CC) as test article for use during this study.” NCT00884390 ↗ “Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)” NCT01579903 ↗ “Moroctocog alfa ( AF-CC)” NCT00914459 ↗ “Moroctocog alfa (AF-CC)” NCT00543439 ↗ |
| Known as | B-Domain Deleted Recombinant Factor VIII | “Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery” NCT00243659 ↗ |
| Known as | B-domain Deleted Recombinant Human Factor VIII | “ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII)” NCT00168051 ↗ |
| Known as | BDDrFVIII | “An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients...” NCT00037544 ↗2“Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery” NCT00243659 ↗ “ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII)” NCT00168051 ↗ |
| Known as | Moroctocog alfa(AF-CC) | “This study aimed to evaluate the efficacy, safety, and recovery data of moroctocog alfa (AF-CC) in patients with hemophilia participating in two open-label studies, both...” PMID 33269010 ↗ Nov 2020 |
| Known as | Recombinant factor VIII | “ReFacto (Recombinant factor VIII) and Tranexamic acid” NCT00279578 ↗ |
| Known as | ReFacto | “Refacto” NCT01051544 ↗ |
| Known as | ReFacto AF | “moroctocog alfa (AF-CC) (ReFacto AF)” NCT00884390 ↗ |
| Known as | Xyntha | “This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC)) in male patients less than 6 years old.” NCT00759655 ↗ |
| Known as | Xyntha (Moroctocog-alfa (AF-CC) | “Xyntha (Moroctocog-alfa (AF-CC)” NCT02492984 ↗ |
| Modality | Protein / enzyme biologic | “B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII)” NCT00038935 ↗ |
| Route | Other | “administered by either bolus injections (BI) or continuous infusion (CI)” NCT00243659 ↗ |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL2109137 ↗ |