NCT03452540

Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis

A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients With Acute Decompensated Alcoholic Hepatitis.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Afimmune · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomised, double-blind, placebo-controlled, phase II study is to assess the efficacy and safety of orally administered DS102 in adult patients with acute decompensated alcoholic hepatitis

Conditions

• Severe Acute Decompensated Alcoholic Hepatitis

Interventions

Type	Name	Description
DRUG	1000mg DS102 (BID)	Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.

Timeline

• Start date: 2018-11-28
• Primary completion: 2019-06-19
• Completion: 2020-03-31
• First posted: 2018-03-02
• Last updated: 2022-07-29
• Results posted: 2022-07-29

Locations

8 sites across 2 countries: United States, Georgia

Regulatory

• FDA-regulated drug study