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A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03678480
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : July 27, 2020
Information provided by (Responsible Party):
HighTide Biopharma Pty Ltd

Brief Summary:
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Adolescent Drug: HTD1801 Drug: Ursodeoxycholic Acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : October 4, 2021
Estimated Study Completion Date : November 4, 2021

Arm Intervention/treatment
Experimental: HTD1801 500 mg BID (twice daily), or 1000 mg/day
HTD1801 tablets in double-blind capsules, 250 mg
Drug: HTD1801
HTD1801 capsules, 250mg

Active Comparator: Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day
UDCA tablets in double-blind capsules, 250 mg
Drug: Ursodeoxycholic Acid
UDCA capsules, 125mg

Primary Outcome Measures :
  1. change in gamma-glutamyl transferase (GGT) [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. percentage of patients whose GGT normalizes to <50 units/liter [ Time Frame: 18 weeks ]
  2. change in aspartate aminotransferase (AST) [ Time Frame: 18 weeks ]
  3. change in alanine aminotransferase (ALT) [ Time Frame: 18 weeks ]
  4. change in alkaline phosphatase (ALP) [ Time Frame: 18 weeks ]
  5. change in total bilirubin [ Time Frame: 18 weeks ]
  6. change in C-reactive protein (CRP) [ Time Frame: 18 weeks ]
  7. incidence of adverse events [ Time Frame: 18 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Weight ≥ 35 kg
  • Previous cholangiographic evidence of PSC by magnetic resonance cholangiopancreatography (MRCP) or direct cholangiography or liver biopsy findings
  • Serum GGT ≥ 2 × upper limit of normal (ULN)
  • On a stable UDCA treatment regimen for ≥ 8 weeks

Exclusion Criteria:

  • Secondary sclerosing cholangitis
  • Percutaneous or endoscopically-placed biliary drain or stent
  • History of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year
  • Ascending cholangitis requiring intravenous antibiotic therapy within 60 days prior to Screening
  • Concomitant overlap syndrome with primary biliary cholangitis (PBC)
  • Significant hepatic decompensation
  • Alternative causes of chronic liver disease
  • Hospitalization for colitis within 30 days prior to Screening
  • Serum creatinine > 1.2 x ULN
  • Hemoglobin < 10 g/dL
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03678480

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Contact: Cathryn Bennett, B.N., R.N., C.C.R.A. 1-760-809-3523

Sponsors and Collaborators
HighTide Biopharma Pty Ltd
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Responsible Party: HighTide Biopharma Pty Ltd Identifier: NCT03678480    
Other Study ID Numbers: HTD1801.PCT006
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis, Sclerosing
Digestive System Diseases
Gastrointestinal Diseases
Biliary Tract Diseases
Bile Duct Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents