NCT03678480WithdrawnPhase 2
A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Primary Endpoint
- change in gamma-glutamyl transferase (GGT)
Study Overview
Brief Summary
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
HTD1801 500 mg BID (twice daily), or 1000 mg/day
Experimental
HTD1801 tablets in double-blind capsules, 250 mg
Intervention: HTD1801 (Drug)
Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day
Active Comparator
UDCA tablets in double-blind capsules, 250 mg
Intervention: Ursodeoxycholic Acid (Drug)
Outcomes
Primary Outcomes
change in gamma-glutamyl transferase (GGT)
Time Frame: 18 weeks
Secondary Outcomes
- change in C-reactive protein (CRP)(18 weeks)
- percentage of patients whose GGT normalizes to <50 units/liter(18 weeks)
- change in aspartate aminotransferase (AST)(18 weeks)
- change in alanine aminotransferase (ALT)(18 weeks)
- change in alkaline phosphatase (ALP)(18 weeks)
- change in total bilirubin(18 weeks)
- incidence of adverse events(18 weeks)
Investigators
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