Drugs / KW-3357
KW-3357
also known as
ATRYN · Recombinant Antithrombin · rhAT · Antithrombin (Recombinant) · Antithrombin alfa · rAT
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | ATryn | — | 2018-12-22 | europa.eu ↗ |
| Approved | EU (EMA) | ATryn | — | 2006-07-28 | europa.eu ↗ |
Trials 10 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03090893 | Jun 2018 → Jun 2019 | hereditary antithrombin deficiency | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT01598883 | Jun 2012 → Dec 2014 | — | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01158729 | Aug 2011 → Dec 2013 | — | Medical College of Wisconsin | Terminated | No outcome recorded |
| Phase 1 | NCT00938288 | Apr 2009 → Dec 2010 | hereditary antithrombin deficiency | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00506519 | Jul 2007 → Mar 2009 | disseminated intravascular coagulation | LEO Pharma | Terminated | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01384409 | Feb → Oct 2012 | disseminated intravascular coagulation | Kyowa Kirin, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01384396 | Dec 2011 → Apr 2013 | disseminated intravascular coagulation | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01384903 | Jun 2011 → May 2013 | disseminated intravascular coagulation | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT01913444 | Jul 2013 → Oct 2014 | — | Children's Hospital Los Angeles | Withdrawn | No outcome recorded |
| Phase 4 | NCT01547728 | Feb 2012 → Feb 2014 | thrombophilia | Mayo Clinic | Terminated | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | KW-3357 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01384903 ↗ |
| Known as | Antithrombin (Recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01158729 ↗ |
| Known as | Antithrombin alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00506519 ↗ |
| Known as | ATRYN | “Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis” NCT00506519 ↗4“continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®)” NCT03090893 ↗ “recombinant antithrombin (rhAT, ATRYN ®)” NCT01547728 ↗ |
| Known as | rAT | “recombinant antithrombin (rAT) (ATRYN)” NCT01547728 ↗ |
| Known as | Recombinant Antithrombin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01913444 ↗ |
| Known as | rhAT | “continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®)” NCT03090893 ↗1“recombinant antithrombin (rhAT, ATRYN ®)” NCT01547728 ↗ |
| Action | Restore | “Antithrombin replacement therapy is often administered during these periods” NCT00938288 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Human Antithrombin (ATryn®)” NCT00506519 ↗ |
| Route | Intravenous | “continuous intravenous (IV) infusion over five days” NCT00506519 ↗ |