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

Durect

Status and phase: Terminated; Phase 2

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: DUR-928

Study type: Interventional

Funder types: Industry

Identifiers

NCT03394781

C928-008

Details and patient eligibility

About

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).

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

DUR-928 10 mg

Experimental group

Description:

10 mg oral suspension

Treatment:

Drug: DUR-928

DUR-928 50 mg

Experimental group

Description:

50 mg oral suspension

Treatment:

Drug: DUR-928