A POC and Dose-Ranging Study of HTD1801 in PSC Patients



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/14/2019
Start Date:February 9, 2018
End Date:February 3, 2020
Contact:S Gamble, Ph. D.
Email:clinical.trials@hightidetx.com
Phone:301-801-8815

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A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)

This study evaluates HTD1801 in the treatment of Primary Sclerosing Cholangitis (PSC) in
adults. The subjects will be randomised to 3 treatment groups, to receive 500mg, 1000mg and
placebo, bid.


Inclusion Criteria:

- Male or female between 18 and 75 years of age;

- Have a clinical diagnosis of PSC as evident by chronic cholestasis of more than six
months duration with either a consistent magnetic resonance cholangiopancreatography
(MRCP)/endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing
cholangitis;

- If subjects have Inflammatory Bowel Disease (IBD) they will be eligible to
participate. If a subject has IBD, documented evidence of IBD must have been evident
by prior endoscopy or in previous medical records for ≥6 months. In addition, subjects
may only enter the study with a Partial Mayo Score of 0-4, inclusively. Subjects who
are on treatment are allowed, provided they are stable for 3 months if taking:

1. 5-amino salicylic acid drugs,

2. azathioprine,

3. 6-mercaptopurine, or methotrexate

4. biologics;

- Have a serum ALP ≥1.5 × upper limit of normal (ULN);

- Be able to understand and sign a written informed consent form (ICF);

- Subjects receiving allowed concomitant medications need to be on stable therapy for 28
days prior to the Baseline visit, with the exception of ursodeoxycholic acid (UDCA),
which should be stable for at least 6 weeks prior to the Baseline visit.

Exclusion Criteria:

- Presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis,
recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis,
surgical or blunt abdominal trauma, recurrent pyogenic cholangitis,
choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other
cause of secondary sclerosing cholangitis) on prior clinical investigations;

- Small duct PSC;

- Presence of percutaneous drain or bile duct stent;

- History of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1
year by MRCP/ERCP. Presence of dominant stricture without ERCP evidence of
cholangiocarcinoma is acceptable if stable for ≥ 1 year;

- Ascending cholangitis within 60 days prior to Screening;

- History of alcohol or substance abuse or dependence;

- Prior or planned liver transplantation;

- Presence of alternative causes of chronic liver disease, including alcoholic liver
disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, autoimmune
hepatitis;

- Platelet count below 125,000/mm3, albumin below 3.0 g/dL, International Normalized
Ratio (INR) > 1.2, or a history of ascites, or encephalopathy, or history of
esophageal variceal bleeding;

- Severe active IBD or flare in colitis activity within the last 90 days requiring
intensification of therapy beyond baseline treatment;
We found this trial at
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sites
Lakewood Ranch, Florida 34211
Phone: 941-727-7772
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-4295
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Cynthia Levy, MD
Phone: 305-243-4615
University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Michael Porayko, MD
Phone: 615-936-1745
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Charles Landis, MD, PhD
Phone: 206-744-7063
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Lisa Forman, MD
Phone: 303-724-1866
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Austin, Texas 78746
Phone: 512-384-4560
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Phone: 301-295-4451
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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1955 West Frye Road
Chandler, Arizona 85224
Phone: 480-686-8874
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Fayetteville, North Carolina 28304
Phone: 910-484-8163
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2510 Lakeland Drive
Flowood, Mississippi 39232
Phone: 601-863-0395
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Germantown, Tennessee 38138
Phone: 901-682-2450
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Matthew C. Cave, MD
Phone: 502-852-3383
University of Louisville The University of Louisville is a state supported research university located in...
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New Haven, Connecticut 06520
Principal Investigator: Marina Silveira, MD
Phone: 203-737-6060
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1 Gustave L. Levy Place
New York, New York 10029
Phone: 212-241-0255
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Kevin Korenblat, MD
Phone: 314-454-0058
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Antonio, Texas 78265
Phone: 210-982-0320
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Kris V. Kowdley, MD
Phone: 206-386-2427
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Tucson, Arizona 85711
Phone: 480-686-8874
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Winston-Salem, North Carolina 27157
Principal Investigator: Sean R. Rudnick, MD
Phone: 336-713-1442
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