Grifols completes enrollment in Phase 3 study of long-term Albutein

Grifols announced it has completed enrollment in PRECIOSA, its phase 3 clinical trial designed to determine the potential of long-term albumin treatment with Grifols Albutein to increase survival time in patients with decompensated cirrhosis and ascites until a suitable transplant is available. Over 400 patients with decompensated cirrhosis with ascites are participating in this multi-center, randomized, controlled, parallel-group, open-label study in 69 sites across North America and Europe. It will evaluate the efficacy and safety of long-term Albutein administration plus standard medical treatment. “There is great potential for albumin to improve the survival prospects of patients suffering from decompensated cirrhosis until they can get a liver transplant, a large unmet need given the limited availability of livers for patients,” said Sandra Camprubi, Grifols Senior Director Clinical Operations. “We look forward to providing topline data from this study in the fourth quarter of 2024 and evaluating next regulatory steps to provide patients with a much-needed treatment.”