fibrinogen (FIB-Grifols) / Grifols - LARVOL DELTA

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

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

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