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NCT03678480 Clinical Trial

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

Primary Sclerosing Cholangitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03678480
Other study ID # HTD1801.PCT006
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date November 4, 2021

Study information
Verified date July 2020
Source HighTide Biopharma Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 4, 2021
Est. primary completion date October 4, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• HTD1801
HTD1801 capsules, 250mg
• Ursodeoxycholic Acid
UDCA capsules, 125mg

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
HighTide Biopharma Pty Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary change in gamma-glutamyl transferase (GGT) 18 weeks
Secondary percentage of patients whose GGT normalizes to <50 units/liter 18 weeks
Secondary change in aspartate aminotransferase (AST) 18 weeks
Secondary change in alanine aminotransferase (ALT) 18 weeks
Secondary change in alkaline phosphatase (ALP) 18 weeks
Secondary change in total bilirubin 18 weeks
Secondary change in C-reactive protein (CRP) 18 weeks
Secondary incidence of adverse events 18 weeks
See also
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