drugset
Drugs / TB-402
last change Jun 2012 re-read 9 days ago

TB-402

Monoclonal antibody targets F8 via inhibition

Developed for
venous thromboembolism
Investigated by
BioInvent International AB · ThromboGenics · Covance

Trials 4

today NCT01344954 · Ph 2 NCT00793234 · Ph 2 NCT00618579 · Ph 1 NCT00612196 · Ph 1
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT00618579 Feb → Jun 2008 — ThromboGenics Completed No outcome recorded
Phase 1 NCT00612196 Mar → Oct 2007 — ThromboGenics Completed No outcome recorded
Phase 22 trials
Phase 2 NCT01344954 Apr → Dec 2011 venous thromboembolism ThromboGenics Completed No outcome recorded
Phase 2 NCT00793234 Dec 2008 → Jan 2010 — ThromboGenics Completed No outcome recorded
Comparator or background therapy1 trial
Phase 1 NCT00612417 Background Jan → Mar 2008 — ThromboGenics Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2012-06-05 BioInvent International AB Results BioInvent and ThromboGenics Announce Results from Phase IIb Venous Thromboembolism Prevention Study with TB-402 bioinvent.com ↗
The study showed that the incidence of venous thromboembolism (VTE) was similar with both drugs but patients receiving TB-402 had a significantly higher incidence of bleeding events.
2011-02-11 BioInvent International AB Results Positive TB-402 (Anti-Factor VIII Antibody) Phase II Data Published in Journal of Thrombosis and Haemostasis bioinvent.com ↗
The study showed that TB-402 was associated with a lower rate of VTE compared with enoxaparin.
2010-07-09 BioInvent International AB Results Positive Results from Phase II VTE Prophylaxis Study with TB-402 (Anti-Factor VIII) Presented at the 21st Int. Congress on Thrombosis in Milan, Italy bioinvent.com ↗
2010-05-06 BioInvent International AB Results BioInvent and ThromboGenics Announce Positive Topline Results from Phase II VTE Prophylaxis Study with Anti-Factor VIII (TB-402) bioinvent.com ↗

All press releases naming this drug 9 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as TB-402 “TB-402, a human monoclonal antibody that partially inhibits Factor VIII activity (FVIII:C), is being developed as a long-acting antithrombotic agent.” PMID 20637972 ↗ Jun 2010
4

NCT01344954 ↗

NCT00793234 ↗

NCT00612417 ↗

NCT00618579 ↗
Action Inhibit “TB-402, a human monoclonal antibody that partially inhibits Factor VIII activity (FVIII:C)” PMID 20637972 ↗ Jun 2010
1

“Coagulation factor VIII inhibitor” CHEMBL2109410 ↗
Modality Monoclonal antibody “TB-402, a human monoclonal antibody that partially inhibits Factor VIII activity (FVIII:C)” PMID 20637972 ↗ Jun 2010
Route Intravenous “TB-402 administered as a single intravenous bolus” PMID 20637972 ↗ Jun 2010
Target F8 “Coagulation factor VIII inhibitor” CHEMBL2109410 ↗