Date: 2012-12-06
Type of information:
phase: 1-2
Announcement: approval of the study protocol
Company: Biotest (Germany)
Product: human fibrinogen concentrate
Action
mechanism: Fibrinogen is a clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood’s ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. So far, these patients have been treated primarily with fresh frozen plasma (FFP). Fibrinogen administration based on the point-of-cared diganostic data allows for the first time a tailor-made, patient specific and higly effective therapy. The recently developed manufacturing process is leading to a high-purity fibrinogen with a high level of viral safety and good solubility.
Disease: congenital fibrinogen deficiency
Therapeutic area: Blood diseases - Hematological diseases
Country:
Trial
details: This study investigates whether congenital fibrinogen deficiency can be compensated by the administration of fibrinogen concentrate. Moreover, the study will examine to what extent the administration of fibrinogen concentrate can stop acute bleeding in patients with such a deficiency. Approximately 20 patients in the age between 6 and 75 will be included in this multinational phase I/II study, which will be conducted in several countries.A follow-up study will examine the efficacy of fibrinogen concentrate in treating serious, acquired bleeding complications, which can occur for example during cardio-surgical interventions and/or atonic bleeding after childbirth.
Latest
news: Biotest has started clinical development programme of human fibrinogen concentrate to treat serious, life-threatening bleeding. After approval of the study protocol, the first patient will be included shortly. This study investigates whether congenital fibrinogen deficiency can be compensated by the administration of fibrinogen concentrate.
The global market for fibrinogen for the treatment of serious, acquired bleeding is estimated € 530 million. Biotest aims to cover approximately 20% of the global market with its proprietary development, thus generating additional turnover of € 100 million.
