Clinical trial NCT03394781: A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
Official title: A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Primary Sclerosing Cholangitis
Lead sponsor: Durect
Sponsor class: INDUSTRY
First posted: 2018-01-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Cholangitis (PSC). This trial will also assess safety (side effects).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percent Change of Alkaline Phosphatase (ALP) From Baseline
timeFrame: Day 28 (end of treatment) and Day 56 (end of study/early termination)
Secondary outcomes:
measure: Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
timeFrame: Day 28 and Day 56
measure: Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline
timeFrame: Day 28 (end of treatment) and Day 56 (end of follow-up)
measure: Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period.
timeFrame: Day 28 and Day 56
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research
state: Mississippi
city: Charlotte
country: United States
facility: Charlotte Mecklenburg Hospital
state: North Carolina
Study officials:
affiliation: INC Research/InVentiv Health
name: Alastair Smith, MD
role: STUDY_DIRECTOR
References: