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NCT Number: NCT03678480

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

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

Why the study stopped: Corporate decision
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Key information

Conditions

Primary Sclerosing Cholangitis Adolescent Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HTD1801

Drug

HTD1801 capsules, 250mg

Ursodeoxycholic acid

Drug

UDCA capsules, 125mg

Primary outcomes

  1. change in gamma-glutamyl transferase (GGT)

    Time frame: 18 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

HighTide Therapeutics (Hong Kong) Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2018
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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