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A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)

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ClinicalTrials.gov Identifier: NCT03394781
Recruitment Status : Terminated (poor enrollment)
First Posted : January 9, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Durect

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).

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: DUR-928 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019


Arm Intervention/treatment
Experimental: DUR-928 10 mg
10 mg oral suspension
Drug: DUR-928
oral suspension daily for 28 days

Experimental: DUR-928 50 mg
50 mg oral suspension
Drug: DUR-928
oral suspension daily for 28 days




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: through 4 weeks of dosing until 56 days post-dose ]
  2. Percent change of ALP from baseline [ Time Frame: through 4 weeks of dosing until 56 days post-dose ]

Secondary Outcome Measures :
  1. Percent change of liver enzymes [ Time Frame: through 4 weeks of dosing until 56 days post-dose ]
  2. Percent change of selected biomarkers [ Time Frame: through 4 weeks of dosing until 56 days post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Verified diagnosis of PSC for at least 12 months, with or without IBD.
  • Serum (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

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): NCT03394781


Locations
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United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
United States, Mississippi
Southern Therapy and Advanced Research
Jackson, Mississippi, United States, 39216
United States, North Carolina
Charlotte Mecklenburg Hospital
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Durect
Investigators
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Study Director: Alastair Smith, MD INC Research/InVentiv Health

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Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT03394781     History of Changes
Other Study ID Numbers: C928-008
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases