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Clinical Trials

Date: 2013-05-03

Type of information: Halting of the trial

phase: 2-3

Announcement: discontinuation of the trial

Company: Bayer (Germany)

Product: BAY 86-6150 (recombinant factor VIIa (rFVIIa) protein)

Action mechanism:

Disease:

patients with hemophilia A or B with inhibitors

Therapeutic area: Hematologic diseases - Genetic diseases - Rare diseases

Country:

Trial details:

The TRUST (TReatment with Unique recombinant rFVIIa STudy) trial is a Phase II/III, multicenter, open-label clinical study designed to assess the safety and efficacy of BAY 86-6150, a recombinant factor VIIa (rFVIIa) protein, in patients with hemophilia A or B with inhibitors.

Latest news:

* On May 3, 2013, Bayer HealthCare has announced that a Phase II/III trial evaluating the efficacy and safety of BAY 86-6150 in people with hemophilia A and hemophilia B with inhibitors has been discontinued. The hope that BAY 86-6150 might help patients with inhibitors to achieve better control of their disease could not be fulfilled due to the detection of a neutralizing antibody in the trial.

Is general: Yes