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A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB1020 in Hepatic Insufficiency and Cirrhosis Patients

Trial Profile

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB1020 in Hepatic Insufficiency and Cirrhosis Patients

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 03 Jan 2019

At a glance

  • Drugs SYNB 1020 (Primary)
  • Indications Hyperammonaemia; Liver cirrhosis
  • Focus Adverse reactions
  • Sponsors Synlogic
  • Most Recent Events

    • 03 Jan 2019 According to a Synlogic media release, enrolled and treated an initial open-label sentinel cohort of six subjects with mild disease to ensure safety. This part of the study is complete and company is enrolling patients with more advanced disease with elevated blood ammonia at baseline.
    • 13 Nov 2018 According to a Synlogic media release, Topline data from this clinical trial are now expected in mid-2019 due to slower than expected rates of initiation of clinical trial sites and patient enrollment.
    • 20 Mar 2018 According to a Synlogic media release, Company expects to present top-line data from this trial by year end 2018.
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