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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432260
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
CTI Clinical Trial & Consulting Services
Information provided by (Responsible Party):
Durect

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Alcoholic Hepatitis Drug: DUR-928 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open- Label, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Signals of DUR-928 in Patients With Alcoholic Hepatitis
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : September 9, 2019
Actual Study Completion Date : September 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DUR-928
Dose escalation including 3 doses: 30mg, 90 mg and 150 mg
Drug: DUR-928
Dose escalation including 3 doses: 30mg, 90 mg and 150 mg




Primary Outcome Measures :
  1. Absence of unexpected serious adverse reaction [ Time Frame: Screening to Day 28 ]

Secondary Outcome Measures :
  1. Total exposure (area under the curve) [ Time Frame: Day 1 to Day 3 ]
  2. Maximum plasma concentration (Cmax) [ Time Frame: Day 1 to Day 3 ]
  3. Time at maximum plasma concentration (Tmax) [ Time Frame: Day 1 to Day 3 ]
  4. Elimination half-life [ Time Frame: Day 1 to Day 3 ]
  5. Change in Aspartate Aminotransferase (AST) [ Time Frame: Screening to Day 28 ]
  6. Change in Alanine Aminotransferase (ALT) [ Time Frame: Screening to Day 28 ]
  7. Change in Bilirubin [ Time Frame: Screening to Day 28 ]
  8. Change in Model for End Stage Liver Disease (MELD) Score [ Time Frame: Screening to Day 28 ]
  9. Change in Lille Model for Alcoholic Hepatitis Score [ Time Frame: Screening to Day 7 ]
  10. Change in high-sensitivity C-Reactive Protein (CRP) [ Time Frame: Screening to Day 28 ]
  11. Change in Interleukin-18 (IL-18) [ Time Frame: Screening to Day 28 ]
  12. Change in Tumor Necrosis Factor (TNF) alpha [ Time Frame: Screening to Day 28 ]
  13. Change in Cytokeratin-18 (CK-18) M65 [ Time Frame: Screening to Day 28 ]
  14. Change in Cytokeratin-18 (CK-18) M30 [ Time Frame: Screening to Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432260


Locations
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United States, California
DURECT Study Site 0001
San Diego, California, United States, 92118
United States, Florida
DURECT Study Site 007
Miami, Florida, United States, 33136
United States, Georgia
DURECT Study Site 0004
Atlanta, Georgia, United States, 30309
United States, Illinois
DURECT Study Site 0002
Chicago, Illinois, United States, 60611
United States, Indiana
DURECT Study Site 008
Indianapolis, Indiana, United States, 46202
United States, Kentucky
DURECT Study Site 0005
Louisville, Kentucky, United States, 40202
United States, Texas
DURECT Study Site 006
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Durect
CTI Clinical Trial & Consulting Services
Investigators
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Study Director: Robert Gordon, MD CTI Clinical Trial & Consulting Services

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Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT03432260    
Other Study ID Numbers: C928-010
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Durect:
Alcoholic Hepatitis
acute alcoholic liver disease
progressive inflammatory liver injury
IV infusion
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders