Drugs / Human Thrombin
Human Thrombin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | TachoSil | — | 2004-06-08 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 2 met primary | ||||||
| Phase 2 | NCT02014402 | Dec 2013 → Nov 2015 | vascular hemostatic disease | Grifols | Completed | Met primary |
| Phase 2 | NCT00658723 | Mar 2008 → Apr 2009 | vascular hemostatic disease | Ethicon, Inc. | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00196534 | Nov 2004 → Jul 2006 | — | Ethicon, Inc. | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT01681030 Comparator | Aug 2012 → Aug 2013 | cardiovascular disorder | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02040428 Comparator | Jan 2014 → Jul 2015 | cardiovascular disorder | Ethicon, Inc. | Completed | Met primary |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Human Thrombin | “Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen...” NCT00658723 ↗4“Equine collagen with Human Fibrinogen and Human Thrombin” NCT02040428 ↗ “Equine collagen with Human Fibrinogen and Human Thrombin” NCT01681030 ↗ |
| Known as | Topical Thrombin (Human) Grifols | “Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery” NCT02014402 ↗ |
| Known as | TTH-Grifols | “evaluated the hemostatic efficacy and safety of plasma-derived topical thrombin (human) Grifols (TTH-Grifols; Instituto Grifols SA) vs bovine THROMBIN JMI (BT-JMI; GenTrac Inc)...” PMID 31376435 ↗ Jul 2019 |
| Modality | Protein / enzyme biologic | “Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery.” PMID 18241525 ↗ Jan 2008 |
| Route | Topical | “human (n = 153) or bovine (n = 152) thrombin, applied topically with an absorbable gelatin sponge.” PMID 18241525 ↗ Jan 2008 |