Clinical Trials

 

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

Intervention Type: Drug
Study Type: Interventional
Sponsors: HighTide Biopharma Pty Ltd
Abstract
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
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Eligibilities
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: No
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

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