A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2019-09-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DUR-928 in Patients With Alcoholic Hepatitis

NCT03917407

Alcoholic Hepatitis

COMPLETED PHASE2

Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide.

NCT04311489

Cirrhosis, Liver Ascites Hepatic

TERMINATED PHASE2

Clinical Impacts of Achieving SVR in Patients With Advanced Hepatic Fibrosis Related to Chronic HCV Treated With Direct Acting Antivirals

NCT03884062

HCC in Chronic HCV Patients With Advanced Liver Fibrosis

COMPLETED

Use of F-652 in Patients With Alcoholic Hepatitis

NCT02655510

Alcoholic Hepatitis

COMPLETED PHASE1/PHASE2

MRG-001 in Patients With Alcoholic Hepatitis

NCT06307522

Alcoholic Hepatitis Acute Alcoholic Hepatitis

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcoholic Hepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Staggered parallel design.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A (Moderate AH) DUR-928 30 mg

Lowest dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg

Group Type EXPERIMENTAL

DUR-928 30 mg

Intervention Type DRUG

Lowest dose of 3 dose escalation arms.

Part A (Moderate AH) DUR-928 90 mg

Middle dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg

Group Type EXPERIMENTAL

DUR-928 90 mg

Intervention Type DRUG

Middle dose of 3 dose escalation arms.

Part A (Moderate AH) DUR-928 150 mg

Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg

Group Type EXPERIMENTAL

DUR-928 150 mg

Intervention Type DRUG

Highest dose of 3 dose escalation arms.

Part B (Severe AH) DUR-928 30 mg

Lowest dose of dose escalation arms: 30mg, 90 mg and 150 mg

Group Type EXPERIMENTAL

DUR-928 30 mg

Intervention Type DRUG

Lowest dose of 3 dose escalation arms.

Part B (Severe AH) DUR-928 90 mg

Middle dose of dose escalation arms: 30mg, 90 mg and 150 mg

Group Type EXPERIMENTAL

DUR-928 90 mg

Intervention Type DRUG

Middle dose of 3 dose escalation arms.

Part B (Severe AH) DUR-928 150 mg

Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg

Group Type EXPERIMENTAL

DUR-928 150 mg

Intervention Type DRUG

Highest dose of 3 dose escalation arms.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DUR-928 30 mg

Lowest dose of 3 dose escalation arms.

Intervention Type DRUG

DUR-928 90 mg

Middle dose of 3 dose escalation arms.

Intervention Type DRUG

DUR-928 150 mg

Highest dose of 3 dose escalation arms.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Able to provide written informed consent (either from patient or patient's legally acceptable representative)
2. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2
3. Patients with alcoholic hepatitis defined as:

1. History of heavy alcohol abuse: \> 40 g/day in females or \> 60 g/day in males for a minimum period of 6 months, AND
2. Consumed alcohol within 12 weeks of entry into the study, AND
3. Serum bilirubin \> 3 mg/dL AND AST \> ALT, but less than 300 U/L AND
4. MELD score between 11-30, inclusive
4. No evidence of active infection as determined by the investigator.
5. Women of child-bearing potential must utilize appropriate birth control throughout the study duration.
6. Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration

Exclusion Criteria

1. Other or concomitant cause(s) of liver disease as a result of:

1. Autoimmune liver disease
2. Wilson disease
3. Vascular liver disease
4. Drug induced liver disease
2. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B
3. Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
4. If female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding
5. Serum creatinine \> 2.5 mg/dL
6. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant
7. Stage 3 or greater encephalopathy by West Haven criteria

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No