Therapeutic innovation

PRECIOSA: Effects of long-term administration of human albumin in subjects with decompensated cirrhosis and ascites

The issue

Current clinical guidelines recommend the administration of short-term albumin in patients with spontaneous bacterial peritonitis, large volume paracentesis or acute kidney injury/hepatorenal syndrome. The ANSWER study suggested that long-term albumin administration (for 18 months) improves survival in cirrhotic patients with ascites requiring moderate doses of diuretics. However, this strategy is poorly applied in clinical practice mainly due to two reasons: logistical problems given the high amount of candidates, and a survival benefit of “only” 11%.

The approach

The PRECIOSA study is a phase III, multicenter, randomized, open-label trial that will include 410 patients with decompensated liver cirrhosis with ascites at high risk of acute-on-chronic liver failure (ACLF) and short-term mortality (CLIF-C AD1 score > 49) aimed to determine whether long-term albumin administration (1.5 g/kg body weight every 10 days for 12 months) improves 1-year transplant-free survival in comparison with standard medical treatment. The study is being performed in 35 centers across Europe and North America.

The PRECIOSA randomized clinical trial is an ambitious project promoted by Grifols aimed at confirming the results of the Answer study, concretely that long-term albumin administration improves survival in patients with cirrhosis and ascites. The target population is however substantially different. In the PRECIOSA trial patients must have a clinical decompensation requiring hospitalization, poor liver function and high risk of ACLF estimated by a CLIF-C AD score > 49 points. If the results of this study are positive, two large randomized clinical trials would provide evidence that periodic albumin administration improves survival in a specific subset of cirrhotic patients with ascites, establishing the rationale for the implementation of this treatment in clinical practice. We are quite close to have the final answer since the last patient is estimated to be recruited by May 2023.

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