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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03394781
Other study ID # C928-008
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date January 22, 2018
Est. completion date January 31, 2019

Study information

Verified date August 2022
Source Durect
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Drug:
DUR-928
oral suspension daily for 28 days

Locations

Country Name City State
United States Charlotte Mecklenburg Hospital Charlotte North Carolina
United States Southern Therapy and Advanced Research Jackson Mississippi
United States Mayo Clinic Florida Jacksonville Florida
United States California Pacific Medical Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Durect

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change of Alkaline Phosphatase (ALP) From Baseline Day 28 (end of treatment) and Day 56 (end of study/early termination)
Secondary Percent Change of Liver Enzymes and Serum Bile Acids (sBA) Liver enzymes include alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), bilirubin.
Percent change from baseline through the end of study treatment (Day 28) and throughout the follow-up period (Day 56).
Day 28 and Day 56
Secondary Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline Day 28 (end of treatment) and Day 56 (end of follow-up)
Secondary Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period. Day 28 and Day 56
See also
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