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