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Can a new drug outperform standard care for a rare liver disease in teens?

NCT ID NCT03678480

Disease control Sponsor: HighTide Therapeutics (Hong Kong) Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether an experimental drug called HTD1801 can improve liver health in adolescents with primary sclerosing cholangitis (PSC), a rare disease that damages the bile ducts. Participants will receive either HTD1801 or the standard treatment, ursodeoxycholic acid (UDCA), to compare their effects on liver enzyme levels. The study aims to see if HTD1801 can reduce markers of liver damage better than the current therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HTD1801 capsules, 250mg, compared to ursodeoxycholic acid (UDCA) capsules, 125mg
What this could lead to
If successful, HTD1801 could offer a new treatment option for adolescents with primary sclerosing cholangitis, potentially improving liver health and slowing disease progression.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not be conclusive. The drug may not prove more effective than UDCA, and there could be unforeseen side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Mar 2021

An estimate. Start dates often move.

Expected to finish

Nov 2021

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bile duct disorder biliary tract disorder cholangitis Cholangitis, Sclerosing Digestive System Diseases digestive system disorder primary sclerosing cholangitis sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adolescent Bile duct diseases Biliary tract diseases Cholangitis Cholangitis, sclerosing Digestive system diseases Primary sclerosing cholangitis

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