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

NCT03678480 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-02-15

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

HTD1801

HTD1801 capsules, 250mg

DRUG

Ursodeoxycholic Acid

UDCA capsules, 125mg

Sponsors & Collaborators

  • HighTide Biopharma Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-10-04
Completion
2021-11-04
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03678480 on ClinicalTrials.gov