Status:
COMPLETED
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
Lead Sponsor:
Durect
Collaborating Sponsors:
CTI Clinical Trial and Consulting Services
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 wit...
Eligibility Criteria
Inclusion
- Able to provide written informed consent (either from patient or patient's legally acceptable representative)
- Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2
- Patients with alcoholic hepatitis defined as:
- History of heavy alcohol abuse: \> 40 g/day in females or \> 60 g/day in males for a minimum period of 6 months, AND
- Consumed alcohol within 12 weeks of entry into the study, AND
- Serum bilirubin \> 3 mg/dL AND AST \> ALT, but less than 300 U/L AND
- MELD score between 11-30, inclusive
- No evidence of active infection as determined by the investigator.
- Women of child-bearing potential must utilize appropriate birth control throughout the study duration.
- Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration
Exclusion
- Other or concomitant cause(s) of liver disease as a result of:
- Autoimmune liver disease
- Wilson disease
- Vascular liver disease
- Drug induced liver disease
- Co-infection with human immunodeficiency virus (HIV) or Hepatitis B
- Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
- If female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding
- Serum creatinine \> 2.5 mg/dL
- Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant
- Stage 3 or greater encephalopathy by West Haven criteria
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03432260
Start Date
April 18 2018
End Date
September 9 2019
Last Update
September 24 2024
Active Locations (7)
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1
DURECT Study Site 0001
San Diego, California, United States, 92118
2
DURECT Study Site 007
Miami, Florida, United States, 33136
3
DURECT Study Site 0004
Atlanta, Georgia, United States, 30309
4
DURECT Study Site 0002
Chicago, Illinois, United States, 60611