fibrinogen concentrate (human) (BT524) / Grifols - LARVOL DELTA

Evaluation of Pharmacokinetics, Efficacy and Safety of a New Human Fibrinogen Concentrate in Patients with Congenital Fibrinogen Deficiency (ASH 2024) - P=N/A | "The aim of this trial was to evaluate the pharmacokinetic/pharmacodynamic (PK/PD) parameters, surrogate efficacy and safety of a novel plasma-derived human fibrinogen concentrate (HFC) (BT524, Biotest AG) in patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia. Conclusions : This trial showed the PK/PD profile of this novel HFC in patients with CFD. The HFC effectively increased antigen levels and activity, restored clot formation, and demonstrated a favorable safety and tolerability profile across all age groups."

Clinical • PK/PD data • Cardiovascular • Pediatrics

Pharmacokinetics, Hemostatic Efficacy, and Safety of a New Human Fibrinogen Concentrate in Adult and Pediatric Patients with Congenital Fibrinogen Deficiency. (PubMed, Thromb Haemost) - "This trial investigated the pharmacokinetic/pharmacodynamic (PK/PD) parameters, and surrogate efficacy and safety of a new human fibrinogen concentrate (HFC), BT524, in patients with congenital afibrinogenemia or severe hypofibrinogenemia.This prospective, multi-national, open-label, single-arm PK/PD trial evaluated PK/PD parameters of HFC (part 1; phase I) and HFC as on-demand treatment or prophylaxis for bleeding events (part 2; phase III). Treatment-related adverse events were rare, with one mild increase in fibrin D-dimer. No thromboembolic events, hypersensitivity, or allergic reactions were observed.HFC effectively increased FiAg levels and FiAc, improved clot firmness, and showed a favorable safety and tolerability profile in adult and pediatric patients with congenital fibrinogen deficiency."

Journal • PK/PD data • Allergy • Cardiovascular • Immunology • Pediatrics

Evaluating the Use of Fibrinogen Concentrate or Fresh Frozen Plasma During Major Spinal Surgeries (ASA 2025) - P3 | "Background: The AdFIrst trial (NCT03444324) showed that human fibrinogen concentrate (BT524, Biotest) was non-inferior to fresh frozen plasma (FFP) or cryoprecipitate (Cryo) for managing severe hemorrhage in patients undergoing elective major spinal surgeries, in a post-hoc analysis fibrinogen concentrate even showed a statistically significant superiority in efficacy. This study supports the use of fibrinogen concentrate as an efficacious, timely effective and safe hemostatic agent in patients with severe hemorrhage undergoing major spinal surgery."

Surgery • Anemia • Hematological Disorders • Hypotension • Infectious Disease

Intraoperative Use of Human Fibrinogen Concentrate in Patients Undergoing Major Abdominal Surgery (ASA 2025) - P3 | "The AdFIrst trial (NCT03444324) demonstrated that fibrinogen replacement therapy with HFC (BT524, Biotest) was non-inferior to cryoprecipitate for managing severe hemorrhage in patients undergoing elective major abdominal surgery. HFC effectively corrected fibrinogen levels and demonstrated a favorable safety profile and similar outcomes than cryoprecipitate in terms of transfusion product usage. HFC was confirmed as an effective alternative to cryoprecipitate for fibrinogen replacement therapy in the perioperative setting."

Clinical • Surgery • Cardiovascular • Hematological Disorders

Efficacy and safety of human fibrinogen concentrate (BT524) in patients with major haemorrhage undergoing major orthopaedic or abdominal surgery (AdFIrst): a randomised, active-controlled, multicentre, partially blinded, phase 3 non-inferiority trial. (PubMed, EClinicalMedicine) - P3 | "The efficacy and safety advantages observed in this trial support the emerging adoption of first-line use of FC in treatment guidelines. Biotest AG, Germany."

Head-to-Head • Journal • P3 data • Cardiovascular • Orthopedics

Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency (clinicaltrials.gov) - P3 | N=67 | Completed | Sponsor: Biotest | N=36 ➔ 67

Enrollment change

PROSPECTIVE, OPEN-LABEL, PHASE I/III STUDY OF THE PHARMACOKINETICS, EFFICACY AND SAFETY OF A FIBRINOGEN CONCENTRATE FROM HUMAN PLASMA, FOR THE TREATMENT AND PROPHYLAXIS OF BLEEDING IN PATIENTS WITH CONGENITAL FIBRINOGEN DEFICIENCY (EHA 2025) - P=N/A | "Aims: In this study, BT524, a human plasma-derived fibrinogen concentrate (FC), was investigated in patients with CFD. The clinical efficacy and safety of FC was demonstrated in this study after single or repeated administration in patients with CFD as evidenced by the overall hemostatic response and other clinical parameters. This was seen with both ODP and ODT administration comprising different types of major and minor, spontaneous, surgical and post-trauma bleeding events."

Clinical • PK/PD data • Cardiovascular • Hematological Disorders • Pediatrics • Rare Diseases • Thrombosis

AdFIrst: Adjusted Fibrinogen Replacement Strategy (clinicaltrials.gov) - P3 | N=222 | Completed | Sponsor: Biotest | N=339 ➔ 222

Enrollment change • Hematological Disorders

A new human fibrinogen concentrate for the management of severe bleeding in patients undergoing major spinal or abdominal surgery: the AdFIrst prospective, randomized study (Euroanaesthesia 2025) - "Patients with severe bleeding undergoing major spinal or abdominal surgery with clinically relevant blood loss were randomized (1:1) for intravenous administration of either HFC (BT524, Biotest) versus FFP or cryoprecipitate. Overall, a higher proportion of patients successfully corrected fibrinogen levels in the HFC (81.3%) vs FFP/cryo (44.2%) groups (p<0.001).Conclusion(s): HFC was efficacious as an early treatment maintaining hemostasis during intra-operative bleeding in patients undergoing major surgeries. In the HFC group, this was achieved through an effective increase and maintenance of fibrinogen levels and a shorter time to fibrinogen level correction compared to standard of care."

Clinical • Surgery

AdFIrst: Adjusted Fibrinogen Replacement Strategy (clinicaltrials.gov) - P3 | N=339 | Completed | Sponsor: Biotest | N=222 ➔ 339

Enrollment change • Surgery • Hematological Disorders

AdFIrst: Adjusted Fibrinogen Replacement Strategy (clinicaltrials.gov) - P3 | N=222 | Completed | Sponsor: Biotest | Recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Oct 2023 | Trial primary completion date: Dec 2022 ➔ Sep 2023

Surgery • Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders

Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency (clinicaltrials.gov) - P3 | N=36 | Completed | Sponsor: Biotest | Unknown status ➔ Completed

Trial completion