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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2019-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DUR-928 10 mg

10 mg oral suspension

Group Type EXPERIMENTAL

DUR-928

Intervention Type DRUG

oral suspension daily for 28 days

DUR-928 50 mg

50 mg oral suspension

Group Type EXPERIMENTAL

DUR-928

Intervention Type DRUG

oral suspension daily for 28 days

Interventions

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DUR-928

oral suspension daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No