Therapy has the potential to decrease mortality rates in patients with decompensated cirrhosis.
Grifols – a company concentrating on plasma-derived treatments – has announced that enrolment has been finalised for its pivotal PRECIOSA clinical trial.
The phase 3 study has been developed in order to establish the potential of long-term albumin treatment using Grifols’ Albutein. The therapy is designed to increase survival time among patients with decompensated cirrhosis and ascites, until such time as a suitable transplant becomes available.
More than 400 patients with the two serious conditions are taking part in the multi-location, randomised open-label study across 69 sites across North America and Europe. The research will evaluate the safety and efficacy of long-term Albutein administration, alongside standard medical treatment.
Albumin – the most abundant protein in plasma – contains antioxidant and anti-inflammatory properties with the potential to alleviate complications linked with decompensated cirrhosis and its progression into acute-on-chronic liver failure (ACLF).
Incorporating albumin therapy has the potential to decrease the high one-year mortality rates typically observed in decompensated cirrhosis.
Sandra Camprubi, senior director, of clinical operations at Grifols, was optimistic about the phase 3 trial: “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.”
She added: “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.”