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

• Status: Withdrawn
• Trial end date: 2021-11-04
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HighTide Biopharma Pty Ltd
• Treatments: Ursodeoxycholic Acid

Criteria

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