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

NCT03452540 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-07-29

Study results available
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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

DRUG

1000mg DS102 (BID)

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

Sponsors & Collaborators

  • Afimmune

    lead INDUSTRY

Principal Investigators

  • Mark Thursz · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2019-06-19
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States
  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452540 on ClinicalTrials.gov