Grifols has completed the enrolment of patients in its Phase III PRECIOSA clinical trial of long-term Albutein (albumin-human injection) therapy to increase the survival time in patients with decompensated cirrhosis.
The open-label, controlled, randomised, parallel-group, multi-centre study is designed to assess the safety and efficacy of Grifols Albutein, along with standard medical treatment, in decompensated cirrhosis patients who are awaiting a transplant.
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It has enrolled more than 400 patients across 69 sites in Europe and North America.
They will be randomised into a 1:1 ratio to receive Albutein or standard of care every eight to 12 days for up to 12 months.
Grifols Clinical Operations senior director Sandra Camprubi said: “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.
“We look forward to providing topline data from this study in the fourth quarter of 2024 and evaluating the next regulatory steps to provide patients with a much-needed treatment.”
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By GlobalDataPatients with decompensated cirrhosis experience several complications, including bacterial infections, variceal bleeding, hepatic encephalopathy, and ascites.
These complications lessen patients’ survival rate to two to four years, compared to compensated cirrhosis patients who can survive for ten to 15 years.
With anti-inflammatory and antioxidant properties, Albutein mitigates complications accompanied by decompensated cirrhosis and its progression into the next stage of acute-on-chronic liver failure.
Albutein has the potential to reduce the high one-year mortality rates observed in decompensated cirrhosis.
