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Home » PDL'S LIVER DISEASE TRIAL SHOWED NO STATISTICAL SIGNIFICANCE
PDL'S LIVER DISEASE TRIAL SHOWED NO STATISTICAL SIGNIFICANCE
August 7, 2006
PDL BioPharma has announced its terlipressin treatment failed to show statistical significance in a Phase III trial of patients with a life-threatening complication of advanced liver disease.
The study to evaluate the safety and the potential effect of terlipressin on kidney function and survival in patients with Type 1 hepatorenal syndrome (HRS) failed to show statistical significance. Type 1 HRS is a life-threatening complication of advanced liver disease characterized by rapidly progressive kidney failure.
The primary endpoint in the trial was treatment success, defined as the percentage of patients alive at day 14 who demonstrated reversal of Type 1 HRS. The data showed a positive trend toward treatment success, but did not reach statistical significance, PDL said.
The company said will work with Orphan Therapeutics, which co-developed terlipressin and conducted the trial, to further analyze the results.
KEYWORDS Drug Pipeline Alert
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