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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03678480

Enrollment

Registered

2018-09-19

Start date

2021-03-01

Completion date

2021-11-04

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

DRUGHTD1801

HTD1801 capsules, 250mg

DRUGUrsodeoxycholic Acid

UDCA capsules, 125mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
change in gamma-glutamyl transferase (GGT)	18 weeks

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026