Primary Sclerosing CholangitisPhase 2NCT03678480
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
A Phase 2 study testing HTD1801 and Ursodeoxycholic Acid in people with Primary Sclerosing Cholangitis and Cholangitis, run by HighTide Therapeutics (Hong Kong) Limited.
Trial summary
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing
- What is being tested?
- HTD1801 and Ursodeoxycholic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 4 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
- Conditions
- Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases
- Being tested
- HTD1801, Ursodeoxycholic Acid
- Medical subject headings
- Cholangitis, Sclerosing, Cholangitis, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTD1801Drug
HTD1801 capsules, 250mg
Ursodeoxycholic AcidDrug
UDCA capsules, 125mg
| Study group | Role | What they receive |
|---|---|---|
| HTD1801 500 mg BID (twice daily), or 1000 mg/day | Experimental | HTD1801 tablets in double-blind capsules, 250 mg Receives: Drug: HTD1801 |
| Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day | Active comparator | UDCA tablets in double-blind capsules, 250 mg Receives: Drug: Ursodeoxycholic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in gamma-glutamyl transferase (GGT)
Measured: 18 weeks
Secondary outcomes (7)
percentage of patients whose GGT normalizes to <50 units/liter
Measured: 18 weeks
change in aspartate aminotransferase (AST)
Measured: 18 weeks
change in alanine aminotransferase (ALT)
Measured: 18 weeks
change in alkaline phosphatase (ALP)
Measured: 18 weeks
change in total bilirubin
Measured: 18 weeks
change in C-reactive protein (CRP)
Measured: 18 weeks
incidence of adverse events
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Mar 2021 (estimated)
- Primary completion4 Oct 2021 (estimated)
- Study completion4 Nov 2021 (estimated)
Why it stopped: Corporate decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HighTide Therapeutics (Hong Kong) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678480
- Sponsor's protocol ID
- HTD1801.PCT006
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2018
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)
- ClinicalTrials.gov ID
- NCT03678480
- Acronym / sponsor ID
- HTD1801.PCT006
- Conditions
- Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Corporate decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HighTide Therapeutics (Hong Kong) LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 4 Oct 2021 (estimated)
- Study completion
- 4 Nov 2021 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTD1801 500 mg BID (twice daily), or 1000 mg/day | Experimental | Drug: HTD1801HTD1801 tablets in double-blind capsules, 250 mg |
| Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day | Active comparator | Drug: Ursodeoxycholic AcidUDCA tablets in double-blind capsules, 250 mg |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTD1801HTD1801 capsules, 250mg | Drug | HTD1801 500 mg BID (twice daily), or 1000 mg/day |
| Ursodeoxycholic AcidUDCA capsules, 125mg | Drug | Ursodeoxycholic Acid (UDCA) 250 mg BID, or 500 mg/day |
Primary outcome
change in gamma-glutamyl transferase (GGT)
Time frame: 18 weeks
7 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HTD1801 and Ursodeoxycholic Acid in people with Primary Sclerosing Cholangitis and Cholangitis, run by HighTide Therapeutics (Hong Kong) Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in gamma-glutamyl transferase (GGT) (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.