Trial Profile

A pivotal phase III study of KB-174 in patients with hepatic encephalopathy (HE)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 19 Dec 2019

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At a glance

Drugs KB 174 (Primary)
Indications Hyperammonaemia
Focus Registrational; Therapeutic Use
Sponsors Kaleido Biosciences

Most Recent Events

19 Dec 2019 New trial record
12 Dec 2019 According to a Kaleido Biosciences media release, with recent feedback from the U.S. Food and Drug Administration that the Company may advance directly into a Phase 3 pivotal trial upon filing an Investigational New Drug application (IND) if the Company elects to do so. As a result, Kaleido expects to initiate its next study of KB174 (with the 36 g twice daily dose) evaluating clinical endpoints in patients with HE during the second half of 2020, ahead of a potential IND filing.

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