Pharma Focus Europe

Grifols Successfully Concludes Phase 3 Enrollment for Long-term Albutein® Therapy in Patients With Decompensated Cirrhosis

Wednesday, July 19, 2023

Grifols, a renowned producer of plasma-derived medications, has successfully concluded the enrollment phase for PRECIOSA (NCT03451292), a phase 3 clinical trial. The trial aims to investigate the potential of Grifols Albutein® in providing long-term albumin treatment to increase survival time in patients with decompensated cirrhosis and ascites, bridging the gap until they can receive a suitable liver transplant.

Cirrhosis, a condition leading to permanent liver scarring and potential liver failure, is the primary cause of liver-related deaths worldwide, with over 1.32 million reported in 2017. The prevalence of cirrhosis in the United States is estimated to affect around 1 in 400 adults, including those who progress to decompensated cirrhosis upon experiencing complications like ascites. Ascites, characterized by abdominal fluid buildup, significantly increases the risk of adverse outcomes, including mortality.

Albumin, the most abundant plasma protein, possesses antioxidant and anti-inflammatory properties that may help alleviate complications associated with decompensated cirrhosis and its progression to acute-on-chronic liver failure (ACLF). Utilizing albumin treatment could potentially reduce the high one-year mortality rates observed in decompensated cirrhosis.

The PRECIOSA trial encompasses more than 400 patients with decompensated cirrhosis and ascites, enrolled in multiple centers across North America and Europe. The study follows a randomized (1:1), controlled, parallel-group, open-label design to evaluate the efficacy and safety of long-term Albutein® administration (every 10 ± 2 days for up to 12 months) in conjunction with standard medical treatment.

Sandra Camprubi, Grifols Senior Director of Clinical Operations, expressed the potential impact of albumin in enhancing survival prospects for patients with decompensated cirrhosis, particularly given the limited availability of livers for transplantation.

Grifols remains dedicated to advancing its innovation pipeline, encompassing various plasma and non-plasma programs across different clinical stages, with the common goal of developing potential treatments to improve the quality of life and longevity for patients.

Decompensated cirrhosis is a prevalent and growing issue in developed countries, with approximately 20% global prevalence. This condition leads to complications such as ascites, variceal bleeding, hepatic encephalopathy, and bacterial infections, resulting in poorer survival rates (2-4 years) compared to compensated cirrhosis (10-15 years).

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