A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
Completed · Phase 2
Conditions studied: Alcoholic Hepatitis
In brief
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).
Key facts
- Study ID
- NCT03432260
- Run by
- Durect
- People needed
- 19
- Starts
- 2018-04-18
- Expected to finish
- 2019-09-09
- Last updated by the study team
- 2024-09-24
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- DURECT Study Site 0001 — San Diego, California, United States
- DURECT Study Site 007 — Miami, Florida, United States
- DURECT Study Site 0004 — Atlanta, Georgia, United States
- DURECT Study Site 0002 — Chicago, Illinois, United States
- DURECT Study Site 008 — Indianapolis, Indiana, United States
- DURECT Study Site 0005 — Louisville, Kentucky, United States
- DURECT Study Site 006 — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.