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

• Status: Terminated
• Trial end date: 2019-01-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Durect

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