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A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment

NCT04563026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2024-09-05

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).

Conditions

  • Alcoholic Hepatitis

Interventions

DRUG

DUR-928 30 mg

IV infusion

DRUG

DUR-928 90 mg

IV infusion

DRUG

Placebo+ Standard of Care (SOC)

IV infusion

Sponsors & Collaborators

  • CTI Clinical Trial and Consulting Services

    collaborator OTHER

  • Durect

    lead INDUSTRY

Principal Investigators

  • Robert Gordon, MD, FACS · CTI Clinical Trial and Consulting Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2023-09-06
Completion
2023-09-06
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • France
  • United Kingdom

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 NCT04563026 on ClinicalTrials.gov