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

Primary Sclerosing Cholangitis Clinical Trial

Official title:

A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03394781
• Other study ID #: C928-008
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

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