FDA Issues Guidance on Trials for Treatment of Symptom-Free Cirrhosis

June 14, 2019

Drug sponsors should “be careful” to make sure they’re properly screening treatments for nonalcoholic steatohepatitis (NASH) compensated cirrhosis patients for Phase 3 clinical trials , the FDA says in a new draft guidance.

“Patients should have histological diagnoses of NASH, and other causes of chronic liver disease should be ruled out,” the agency says.

The protocol for trials of treatments for compensated—symptom-free—cirrhosis should rely on patients who already have a cirrhosis diagnosis based on the examination of tissue samples or patients who satisfy “non-histologic criteria” that the sponsor can establish to the FDA’s satisfaction.

“The FDA encourages sponsors to identify biochemical or imaging noninvasive biomarkers that can replace liver biopsies,” the draft guidance states.

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