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An Open- Label, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Signals of DUR-928 in Patients With Alcoholic Hepatitis

Trial Profile

An Open- Label, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Signals of DUR-928 in Patients With Alcoholic Hepatitis

Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Jan 2019

At a glance

  • Drugs DUR 928 (Primary)
  • Indications Alcoholic hepatitis
  • Focus Adverse reactions
  • Sponsors DURECT Corporation
  • Most Recent Events

    • 07 Jan 2019 According to a DURECT Corporation media release, two severe AH patients have been treated at the 30 mg I.V. dose of DUR-928. Upon completing the 30 mg dose group in Part B, the company plans to transition the study to Dr. McClain, who was recently awarded an NIH grant to study DUR-928 in AH patients. After the transition, the trial will be funded via grants and conducted by Dr. McClain.
    • 19 Nov 2018 According to a DURECT Corporation media release, dosing for the low-dose 30 mg cohort (n=4) of Part A (moderate AH patients), has been completed.
    • 19 Nov 2018 According to a DURECT Corporation media release, trial protocol has been amended. The company will now begin enrolling Part B (severe AH patients), starting with the low dose, while it simultaneously continues enrolling Part A at the next higher dose (90 mg). This will enable dosing in severe AH patients in parallel to the moderate patients.
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