fibrinogen (FIB-Grifols) / Grifols - LARVOL DELTA

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FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Instituto Grifols, S.A. | N=32 ➔ 0 | Suspended ➔ Withdrawn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