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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: Phase 2
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

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

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