DGAP-News: Biotest AG: Biotest achieves significant milestone by completing phase I/III clinical trial with fibrinogen
Retrieved on:
Tuesday, May 26, 2020
In the phase I/III study, patients with congenital fibrinogen deficiency were treated with the fibrinogen concentrate (BT524) developed by Biotest in the case of acute bleeding or as prophylactic treatment before surgery.
Key Points:
- In the phase I/III study, patients with congenital fibrinogen deficiency were treated with the fibrinogen concentrate (BT524) developed by Biotest in the case of acute bleeding or as prophylactic treatment before surgery.
- These patients are unable to produce functional fibrinogen themselves, or only insufficiently and are therefore dependent on the administration of external fibrinogen.
- The prospective, open, multicentre phase I/III study investigated the pharmacokinetic properties, efficacy and safety of fibrinogen concentrate in adults and children with congenital fibrinogen deficiency.
- Biotest is also testing the fibrinogen concentrate in this indication in the phase III trial called "ADFIRST".