Albutein 5% (human albumin, 5%) / Grifols - LARVOL DELTA

APACHE: Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5% (clinicaltrials.gov) - P3 | N=275 | Terminated | Sponsor: Grifols Therapeutics LLC | Active, not recruiting ➔ Terminated; Due to corporate business reasons only (non-safety related decision)

Trial termination • Hepatology • Liver Failure

APACHE: Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5% (clinicaltrials.gov) - P3 | N=275 | Active, not recruiting | Sponsor: Grifols Therapeutics LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2026 ➔ Apr 2025 | Trial primary completion date: Oct 2026 ➔ Apr 2025

Enrollment closed • Trial completion date • Trial primary completion date • Hepatology • Liver Failure

EFFICACY AND SAFETY OF PLASMA EXCHANGE WITH HUMAN SERUM ALBUMIN 5% ON SHORT-TERM SURVIVAL IN PATIENTS WITH ACUTE-ON-CHRONIC LIVER FAILURE AT HIGH RISK OF HOSPITAL MORTALITY: APACHE STUDY DESIGN AND PROGRESS (AASLD 2023) - P3 | "PE-A5% is performed using Albutein 5% (Grifols)... APACHE should provide pivotal results on the efficacy and safety of PE-A5% as a potential treatment to improve survival in ACLF (NCT03702920, EudraCT: 2016-001787-10)."

Clinical • Fibrosis • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Liver Failure • Respiratory Diseases • Septic Shock • Transplantation

APACHE: Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5% (clinicaltrials.gov) - P3 | N=380 | Recruiting | Sponsor: Grifols Therapeutics LLC | Trial completion date: Jun 2022 ➔ Oct 2026 | Trial primary completion date: Jun 2022 ➔ Oct 2026

Trial completion date • Trial primary completion date • Hepatology • Liver Failure • Solid Tumor

Safety and tolerability evaluation of PE in patients with Post-Acute Covid-19 Syndrome (PCC) compared to sham plasma exchange (placebo). Evaluación de la seguridad y la tolerabilidad del recambio plasmático en pacientes con síndrome post-COVID-19 (SPC) en comparación con recambio plasmático simulado (placebo). (clinicaltrialsregister.eu) - P2 | N=50 | Ongoing | Sponsor: Fundació FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la Salut i La Ciència

New P2 trial • Infectious Disease • Novel Coronavirus Disease • CRP

APACHE: Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5% (clinicaltrials.gov) - P3; N=380; Recruiting; Sponsor: Grifols Therapeutics LLC; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Dec 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Hepatology • Liver Failure

Results of Grifols' AMBAR clinical trial published in Alzheimer's & Dementia: The Journal of The Alzheimer's Association (PRNewswire) - "Alzheimer's & Dementia: The Journal of the Alzheimer's Association...today has published the results of Grifols' AMBAR study....The findings of the AMBAR clinical trial demonstrate a delay in the cognitive and functional decline in AD patients when their plasma is replaced with albumin and immunoglobulin (plasma-derived proteins) following the process of plasma extraction, using the plasmapheresis technique."

P2/3 data • Alzheimer's Disease • CNS Disorders

Plasma turnover in patients with COVID-19 disease and invasive mechanical ventilation Recambio plasmático en pacientes con enfermedad COVID-19 y ventilación mecánica invasiva (clinicaltrialsregister.eu) - P2; N=116; Ongoing; Sponsor: Fundació Clínic per a la recerca Biomèdica

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy and Safety of Plasma Exchange With Albutein® 5% in Patients With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P2; N=12; Completed; Sponsor: Grifols Therapeutics LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion

APACHE: Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5% (clinicaltrials.gov) - P3; N=380; Recruiting; Sponsor: Grifols Therapeutics LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Efficacy and Safety of Plasma Exchange With Albutein® 5% in Patients With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P2; N=12; Active, not recruiting; Sponsor: Grifols Therapeutics LLC; Recruiting ➔ Active, not recruiting; Trial completion date: Jan 2019 ➔ Oct 2019; Trial primary completion date: Jan 2019 ➔ Oct 2019

Clinical • Enrollment closed • Trial completion date • Trial primary completion date