Status:
TERMINATED
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
Lead Sponsor:
Durect
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholan...
Eligibility Criteria
Inclusion
- Verified diagnosis of primary sclerosing cholangitis (PSC) for at least 12 months, with or without inflammatory bowel disease (IBD).
- Serum alkaline phosphatase (ALP) ≥ 1.5 times ULN and with no \>15% fluctuation in the past 3 months.
- In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.
- Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.
Exclusion
- Presence of documented secondary sclerosing cholangitis or small duct PSC
- Bacterial cholangitis within 30 days prior to Screening
- Presence of percutaneous drain or endoscopic bile duct stent
- History of, or suspicion of cholangiocarcinoma.
- Prior liver transplantation, or currently listed for liver transplantation
- Presence of other concomitant liver diseases
- Moderate to Severe active IBD or flare in colitis activity within the last 3 months
- Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder
- Any active malignant disease (within 3 years), other than non-melanomatous skin cancer
- Human immunodeficiency virus (HIV) infection
- Existing or intended pregnancy, or breast feeding
- Has received medication from another clinical trial within the past 30 days
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03394781
Start Date
January 22 2018
End Date
January 31 2019
Last Update
October 17 2022
Active Locations (4)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
3
Southern Therapy and Advanced Research
Jackson, Mississippi, United States, 39216
4
Charlotte Mecklenburg Hospital
Charlotte, North Carolina, United States, 28203