A Phase 2 interventional study of HTD1801 and Ursodeoxycholic Acid in Primary Sclerosing Cholangitis, Cholangitis and Cholangitis, Sclerosing, sponsored by HighTide Therapeutics (Hong Kong) Limited. Withdrawn. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by HighTide Therapeutics (Hong Kong) Limited · Phase 2, Interventional, and Treatment
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
149 studies on the registry are indexed under Cholangitis, Sclerosing; 39 are open to participants now.
Browse Cholangitis, Sclerosing studies →HighTide Therapeutics (Hong Kong) Limited is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HTD1801 tablets in double-blind capsules, 250 mg
Drug: HTD1801
UDCA tablets in double-blind capsules, 250 mg
Drug: Ursodeoxycholic Acid
HTD1801 capsules, 250mg
UDCA capsules, 125mg
change in gamma-glutamyl transferase (GGT)
Time frame: 18 weeks
percentage of patients whose GGT normalizes to <50 units/liter
Time frame: 18 weeks
change in aspartate aminotransferase (AST)
Time frame: 18 weeks
change in alanine aminotransferase (ALT)
Time frame: 18 weeks
change in alkaline phosphatase (ALP)
Time frame: 18 weeks
change in total bilirubin
Time frame: 18 weeks
change in C-reactive protein (CRP)
Time frame: 18 weeks
incidence of adverse events
Time frame: 18 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2021; primary completion for Oct 2021, 7 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Berberine ursodeoxycholate
HighTide Therapeutics (Hong Kong) Limited