A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
Overview
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).
Full Title of Study: “A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 31, 2019
Interventions
- Drug: DUR-928
- oral suspension daily for 28 days
Arms, Groups and Cohorts
- Experimental: DUR-928 10 mg
- 10 mg oral suspension
- Experimental: DUR-928 50 mg
- 50 mg oral suspension
Clinical Trial Outcome Measures
Primary Measures
- Percent Change of Alkaline Phosphatase (ALP) From Baseline
- Time Frame: Day 28 (end of treatment) and Day 56 (end of study/early termination)
Secondary Measures
- Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
- Time Frame: Day 28 and Day 56
- 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).
- Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline
- Time Frame: Day 28 (end of treatment) and Day 56 (end of follow-up)
- Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period.
- Time Frame: Day 28 and Day 56
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Durect
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Alastair Smith, MD, Study Director, INC Research/InVentiv Health
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