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

HighTide Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Primary Sclerosing Cholangitis; Cholangitis; Bile Duct Diseases; Digestive System Diseases; Adolescent; Cholangitis, Sclerosing; Biliary Tract Diseases

Treatments: Drug: Ursodeoxycholic Acid; Drug: HTD1801

Study type: Interventional

Funder types: Industry

Identifiers

NCT03678480

HTD1801.PCT006

Details and patient eligibility

About

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

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups

HTD1801 500 mg BID (twice daily), or 1000 mg/day

Experimental group

Description:

HTD1801 tablets in double-blind capsules, 250 mg

Treatment:

Drug: HTD1801

Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day

Active Comparator group

Description:

UDCA tablets in double-blind capsules, 250 mg

Treatment:

Drug: Ursodeoxycholic Acid