fibrinogen (FIB-Grifols) / Grifols - LARVOL DELTA

Systematic literature review and meta-analysis on the safety of fibrinogen concentrate versus cryoprecipitate in bleeding surgical patients (ASH 2025) - "This analysis suggests that FC has a favorable safety profile regarding TEEs, as well as AEs and SAEs,compared to cryoprecipitate in patients with surgical bleeding. Due to the limited number andheterogeneity of the identified RCTs, these results should be interpreted with caution, underscoring theneed for additional clinical trials."

Retrospective data • Review • Cardiovascular • Hematological Disorders • Pulmonary Embolism • Respiratory Diseases

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

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

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

Efficacy and Safety of a New Human Fibrinogen Concentrate for Treatment of Bleeding Events in Patients with Congenital Fibrinogen Deficiency (EAHAD 2025) - No abstract available

Clinical

A Phase 3, Randomized, Active-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of Fibrin Sealant Grifols in Achieving Hemostasis in Pediatric Surgery. (PubMed, J Pediatr Surg) - "FS Grifols was safe and effective at achieving hemostasis in pediatric patients having parenchymous or soft tissue surgeries. The efficacy of FS Grifols was non-inferior to Evicel."

Journal • P3 data • Surgery • Pain • Pediatrics

FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Instituto Grifols, S.A. | N=32 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal

Impact of therapeutic and low volume plasma exchange on clinical laboratory parameters in patients treated for Alzheimer's disease from the AMBAR study. (PubMed, Ther Apher Dial) - "Laboratory parameters of AD patients were affected by TPE similarly to effects of PE-treatment for other pathologies. These effects were less pronounced or non-existent for LVPE."

Journal • Alzheimer's Disease • CNS Disorders

"#GRIFOLS . Resultados 2022 de su Filial #BIOTEST Y Espectativas 2023 . El Negocio Principal de Biotest ""ES RENTABLE CON EUR 60,7 MILLONES"" . Biotest Kerngeschäft Mit 60,7 Mio. Euro Profitabel . https://t.co/hb8btZiBaR . #DAX #germany #ibex #NASDAQ @EMA_News @US_FDA #fibrinogen" (@pharma_jonpi)

Pharmacokinetics, efficacy and safety of a novel fibrinogen concentrate in pediatric patients with congenital afibrinogenemia. (PubMed, Blood Coagul Fibrinolysis) - "In pediatric patients with congenital afibrinogenemia, plasma-derived fibrinogen concentrate revealed a favorable and specific pharmacokinetic profile, demonstrated efficacy in coagulation and was safe and well tolerated."

Journal • PK/PD data • Pediatrics

FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis (clinicaltrials.gov) - P3 | N=32 | Suspended | Sponsor: Instituto Grifols, S.A. | Trial completion date: Dec 2023 ➔ Mar 2025 | Trial primary completion date: Jun 2023 ➔ Mar 2025

Trial completion date • Trial primary completion date

FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis (clinicaltrials.gov) - P3; N=32; Suspended; Sponsor: Instituto Grifols, S.A.; Not yet recruiting ➔ Suspended

Clinical • Trial suspension

FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis (clinicaltrials.gov) - P3; N=32; Not yet recruiting; Sponsor: Instituto Grifols, S.A.; Initiation date: Nov 2020 ➔ Mar 2021

Clinical • Trial initiation date

Pharmacokinetics, surrogate efficacy and safety evaluations of a new human plasma-derived fibrinogen concentrate (FIB Grifols) in adult patients with congenital afibrinogenemia. (PubMed, Thromb Res) - "The pharmacokinetic profile of functionally active FIB Grifols was established, hemostasis was restored, and FIB Grifols was safe and well tolerated in fibrinogen-deficient patients."

Clinical • Journal • PK/PD data • Allergy • Hematological Disorders