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

August 8, 2026 updated by: HighTide Therapeutics (Hong Kong) Limited

A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in gamma-glutamyl transferase (GGT)
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
percentage of patients whose GGT normalizes to <50 units/liter
Time Frame: 18 weeks
18 weeks
change in aspartate aminotransferase (AST)
Time Frame: 18 weeks
18 weeks
change in alanine aminotransferase (ALT)
Time Frame: 18 weeks
18 weeks
change in alkaline phosphatase (ALP)
Time Frame: 18 weeks
18 weeks
change in total bilirubin
Time Frame: 18 weeks
18 weeks
change in C-reactive protein (CRP)
Time Frame: 18 weeks
18 weeks
incidence of adverse events
Time Frame: 18 weeks
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HighTide Therapeutics (Hong Kong) Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2021

Primary Completion (Estimated)

October 4, 2021

Study Completion (Estimated)

November 4, 2021

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 8, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTD1801.PCT006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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