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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 : Recruiting
First Posted : January 9, 2018
Last Update Posted : April 19, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 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, Senior)
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


Contacts
Contact: Gwenaelle Mille 408-777-1417 gwenaelle.mille@durect.com

Locations
United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University Not yet recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
United States, Mississippi
Southern Therapy and Advanced Research Recruiting
Jackson, Mississippi, United States, 39216
United States, North Carolina
Charlotte Mecklenburg Hospital Recruiting
Charlotte, North Carolina, United States, 28203
United States, Texas
Texas Liver Institute Recruiting
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Durect
Investigators
Study Director: Alastair Smith, MD INC Research/InVentiv Health

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: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases