A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
NCT ID: NCT03678480
Last Updated: 2021-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-03-01
2021-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HTD1801 500 mg BID (twice daily), or 1000 mg/day
HTD1801 tablets in double-blind capsules, 250 mg
HTD1801
HTD1801 capsules, 250mg
Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day
UDCA tablets in double-blind capsules, 250 mg
Ursodeoxycholic Acid
UDCA capsules, 125mg
Interventions
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HTD1801
HTD1801 capsules, 250mg
Ursodeoxycholic Acid
UDCA capsules, 125mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
17 Years
ALL
No
Sponsors
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HighTide Biopharma Pty Ltd
INDUSTRY
Responsible Party
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Other Identifiers
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HTD1801.PCT006
Identifier Type: -
Identifier Source: org_study_id
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