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



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:6/9/2018
Start Date:January 22, 2018
End Date:January 2019
Contact:Gwenaelle Mille
Email:gwenaelle.mille@durect.com
Phone:408-777-1417

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

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).


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
We found this trial at
10
sites
San Antonio, Texas 78215
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Aurora, Colorado 80045
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Aurora, CO
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Burlington, MA
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1000 Blythe Boulevard
Charlotte, North Carolina 28203
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Charlotte, NC
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Coral Gables, Florida 33146
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Coral Gables, FL
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Jackson, Mississippi 39216
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Jackson, MS
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Jacksonville, FL
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Palo Alto, California 94304
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Palo Alto, CA
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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San Francisco, CA
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