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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
NCT03678480 |
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Date of registration:
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18/09/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
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Scientific title:
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A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC) |
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Date of first enrolment:
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March 1, 2021 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03678480 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cholangitis
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Primary Sclerosing Cholangitis
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Adolescent
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Digestive System Diseases
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Biliary Tract Diseases
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Bile Duct Diseases
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Cholangitis, Sclerosing
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Intervention(s)
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Drug: HTD1801
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Drug: Ursodeoxycholic Acid
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Primary Outcome(s)
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change in gamma-glutamyl transferase (GGT)
[Time Frame: 18 weeks]
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Secondary Outcome(s)
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change in alanine aminotransferase (ALT)
[Time Frame: 18 weeks]
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change in alkaline phosphatase (ALP)
[Time Frame: 18 weeks]
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change in aspartate aminotransferase (AST)
[Time Frame: 18 weeks]
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change in total bilirubin
[Time Frame: 18 weeks]
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change in C-reactive protein (CRP)
[Time Frame: 18 weeks]
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incidence of adverse events
[Time Frame: 18 weeks]
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percentage of patients whose GGT normalizes to <50 units/liter
[Time Frame: 18 weeks]
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Secondary ID(s)
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HTD1801.PCT006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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