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CompletedNCT03333928Updated Aug 25, 2026Results posted

A POC and Dose-Ranging Study of HTD1801 in PSC Patients

A Phase 2 interventional study of HTD1801 and Placebo in Primary Sclerosing Cholangitis (PSC), sponsored by HighTide Therapeutics (Hong Kong) Limited. Completed at 26 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by HighTide Therapeutics (Hong Kong) Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.

02

Conditions studied

  • Primary Sclerosing Cholangitis (PSC)
03

In context

Cholangitis, Sclerosing

149 studies on the registry are indexed under Cholangitis, Sclerosing; 39 are open to participants now.

This study's enrollment of 59 is above the median of 34 across 94 interventional studies indexed under Cholangitis, Sclerosing.

Browse Cholangitis, Sclerosing studies →

Lead sponsor

HighTide Therapeutics (Hong Kong) Limited is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Male or female between 18 and 75 years of age;
  • Have a clinical diagnosis of PSC as evident by chronic cholestasis of more than six months duration with either a consistent magnetic resonance cholangiopancreatography (MRCP)/endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing cholangitis;

  • If subjects have Inflammatory Bowel Disease (IBD) they will be eligible to participate. If a subject has IBD, documented evidence of IBD must have been evident by prior endoscopy or in previous medical records for ≥6 months. In addition, subjects may only enter the study with a Partial Mayo Score of 0-4, inclusively. Subjects who are on treatment are allowed, provided they are stable for 3 months if taking:

    1. 5-amino salicylic acid drugs,
    2. azathioprine,
    3. 6-mercaptopurine, or methotrexate
    4. biologics;
  • Have a serum ALP ≥1.5 × (ULN);
  • Be able to understand and sign a written form (ICF);
  • Subjects receiving allowed concomitant medications need to be on stable therapy for 28 days prior to the Baseline visit, with the exception of ursodeoxycholic acid (UDCA), which should be stable for at least 6 weeks prior to the Baseline visit.

Exclusion criteria

Exclusion Criteria:

  • Presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations;
  • Small duct PSC;
  • Presence of percutaneous drain or bile duct stent;
  • History of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year by MRCP/ERCP. Presence of dominant stricture without ERCP evidence of cholangiocarcinoma is acceptable if stable for ≥ 1 year;
  • Ascending cholangitis within 60 days prior to Screening;
  • History of alcohol or substance abuse or dependence;
  • Prior or planned liver transplantation;
  • Presence of alternative causes of chronic liver disease, including alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, hepatitis;
  • count below 125,000/mm3, albumin below 3.0 g/dL, (INR) > 1.2, or a history of ascites, or encephalopathy, or history of esophageal variceal bleeding;
  • Severe active IBD or flare in colitis activity within the last 90 days requiring intensification of therapy beyond baseline treatment;
Terms in these criteria, in plain language(5)

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.

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Active comparator
    HTD1801 500 mg BID

    Drug: HTD1801

  • Active comparator
    HTD1801 1000 mg BID

    Drug: HTD1801

  • Placebo comparator
    Placebo BID

    Drug: Placebo

Interventions

  • DrugHTD1801

    HTD1801 tablets, 250 mg

  • DrugPlacebo

    tablets manufactured to mimic HTD1801 tablets

06

What researchers measure

Primary outcomes

  1. Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1

    Time frame: Baseline to Week 6

Secondary outcomes

  1. Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1)

    Time frame: Baseline to Week 6

  2. Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1)

    Time frame: Baseline to Week 6

  3. Percentage of Subjects Who Normalize ALP at the End of Week 6 (Period 1)

    Time frame: Baseline to Week 6

  4. Absolute Change in Serum Total Bilirubin at the End of Week 6 (Period 1)

    Time frame: Baseline to Week 6

  5. Absolute Change in Serum ALP From Week 6 to Week 12 (Period 2)

    Time frame: Week 6 to Week 12

  6. Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 12 (Period 2)

    Time frame: Week 6 to Week 12

  7. Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 12 (Period 2)

    Time frame: Week 6 to Week 12

  8. Percentage of Patients Who Normalize ALP at the End of Week 12 (Period 2)

    Time frame: Week 6 to Week 12

  9. Absolute Change in Serum Total Bilirubin at the End of Week 12 (Period 2)

    Time frame: Week 6 to Week 12

  10. Absolute Change in Serum ALP From Week 12 to Week 18 (Period 3)

    Change in serum ALP between a new baseline at Week 12 and the final value at Week 18 for all subjects following the randomized withdrawal

    Time frame: Week 12 to Week 18

  11. Percentage of Patients Who Achieve ALP of <1.5 x ULN at the End of Week 18 (Period 3)

    The percentage of patients who achieve ALP of \<1.5 x ULN at the end of week 18 (Period 3)

    Time frame: Week 12 to Week 18

  12. Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 18 (Period 3)

    Time frame: Week 12 to Week 18

  13. Percentage of Subjects Who Normalize ALP at the End of Week 18 (Period 3)

    Time frame: Week 12 to Week 18

  14. Absolute Change in Serum Total Bilirubin at the End of Week 18 (Period 3)

    Time frame: Week 12 to Week 18

07

Results

Posted Apr 6, 2022

Participant flow

Fifty-nine subjects were recruited from 23 academic medical centers and community clinics in the US and Canada. The first subject was enrolled on 18 June 2018 and the last subject last visit was completed on 10 Aug 2020.

Initial Dosing Period (Period 1)
Participant flow — Initial Dosing Period (Period 1)
Milestone500mg HTD1801 BID1000 mg HTD1801 BIDPlacebo BID
Started162518
Completed152114
Not completed144
Withdrew: Protocol violation001
Withdrew: Withdrawal by subject011
Withdrew: Corporate decision to not initiate dosing in new patients because of covid-19101
Withdrew: Adverse event031
Dose-controlled Extension (Period 2)
Participant flow — Dose-controlled Extension (Period 2)
Milestone500mg HTD1801 BID1000 mg HTD1801 BIDPlacebo BID
Started22290
Completed19280
Not completed310
Withdrew: Adverse event210
Withdrew: Lost to follow-up100
Randomized Withdrawal (Period 3)
Participant flow — Randomized Withdrawal (Period 3)
Milestone500mg HTD1801 BID1000 mg HTD1801 BIDPlacebo BID
Started101426
Completed81425
Not completed201
Withdrew: Adverse event100
Withdrew: Lost to follow-up101

Outcome measures

PrimaryAbsolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1
Time frame:
Baseline to Week 6
Reported as:
Mean · U/L
Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1
U/LHTD1801 500 mg BIDHTD1801 1000 mg BIDPlacebo BID
Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1-71 ± 136.9-73 ± 139.994 ± 261.7
SecondaryPercentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1)
Time frame:
Baseline to Week 6
Reported as:
Count of participants · Participants
Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1)
ParticipantsHTD1801 500 mg BIDHTD1801 1000 mg BIDPlacebo BID
Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1)261
SecondaryPercentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1)
Time frame:
Baseline to Week 6
Reported as:
Count of participants · Participants
Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1)
ParticipantsHTD1801 500 mg BIDHTD1801 1000 mg BIDPlacebo BID
Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1)140
SecondaryPercentage of Subjects Who Normalize ALP at the End of Week 6 (Period 1)
Time frame:
Baseline to Week 6
Reported as:
Count of participants · Participants
Percentage of Subjects Who Normalize ALP at the End of Week 6 (Period 1)
ParticipantsHTD1801 500 mg BIDHTD1801 1000 mg BIDPlacebo BID
Percentage of Subjects Who Normalize ALP at the End of Week 6 (Period 1)020
SecondaryAbsolute Change in Serum Total Bilirubin at the End of Week 6 (Period 1)
Time frame:
Baseline to Week 6
Reported as:
Mean · mg/dL
Absolute Change in Serum Total Bilirubin at the End of Week 6 (Period 1)
mg/dLHTD1801 500 mg BIDHTD1801 1000 mg BIDPlacebo BID
Absolute Change in Serum Total Bilirubin at the End of Week 6 (Period 1)-0.2 ± 0.520.0 ± 0.500.1 ± 0.26
SecondaryAbsolute Change in Serum ALP From Week 6 to Week 12 (Period 2)
Time frame:
Week 6 to Week 12
Reported as:
Mean · U/L
Absolute Change in Serum ALP From Week 6 to Week 12 (Period 2)
U/LPlacebo to HTD1801 500 mg BIDHTD1801 500 mg BID to HTD1801 500 mg BIDPlacebo to HTD1801 1000 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BID
Absolute Change in Serum ALP From Week 6 to Week 12 (Period 2)-34 ± 180.3-14 ± 74.6-189 ± 270.710 ± 65.9
SecondaryPercentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 12 (Period 2)
Time frame:
Week 6 to Week 12
Reported as:
Count of participants · Participants
Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 12 (Period 2)
ParticipantsPlacebo to HTD1801 500 mg BIDHTD1801 500 mg BID to HTD1801 500 mg BIDPlacebo to HTD1801 1000 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BID
Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 12 (Period 2)0206
SecondaryPercentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 12 (Period 2)
Time frame:
Week 6 to Week 12
Reported as:
Count of participants · Participants
Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 12 (Period 2)
ParticipantsPlacebo to HTD1801 500 mg BIDHTD1801 500 mg BID to HTD1801 500 mg BIDPlacebo to HTD1801 1000 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BID
Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 12 (Period 2)1002
SecondaryPercentage of Patients Who Normalize ALP at the End of Week 12 (Period 2)
Time frame:
Week 6 to Week 12
Reported as:
Count of participants · Participants
Percentage of Patients Who Normalize ALP at the End of Week 12 (Period 2)
ParticipantsPlacebo to HTD1801 500 mg BIDHTD1801 500 mg BID to HTD1801 500 mg BIDPlacebo to HTD1801 1000 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BID
Percentage of Patients Who Normalize ALP at the End of Week 12 (Period 2)0002
SecondaryAbsolute Change in Serum Total Bilirubin at the End of Week 12 (Period 2)
Time frame:
Week 6 to Week 12
Reported as:
Mean · mg/dL
Absolute Change in Serum Total Bilirubin at the End of Week 12 (Period 2)
mg/dLPlacebo to HTD1801 500 mg BIDHTD1801 500 mg BID to HTD1801 500 mg BIDPlacebo to HTD1801 1000 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BID
Absolute Change in Serum Total Bilirubin at the End of Week 12 (Period 2)-0.1 ± 0.280.0 ± 0.25-0.4 ± 0.160.0 ± 0.49
SecondaryAbsolute Change in Serum ALP From Week 12 to Week 18 (Period 3)

Change in serum ALP between a new baseline at Week 12 and the final value at Week 18 for all subjects following the randomized withdrawal

Time frame:
Week 12 to Week 18
Reported as:
Mean · U/L
Absolute Change in Serum ALP From Week 12 to Week 18 (Period 3)
U/LHTD1801 500 mg BID to HTD1801 500 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BIDHTD1801 500 mg BID to PlaceboHTD1801 1000 mg BID to Placebo
Absolute Change in Serum ALP From Week 12 to Week 18 (Period 3)-63 ± 88.921 ± 141.7183 ± 292.0142 ± 163.7
SecondaryPercentage of Patients Who Achieve ALP of <1.5 x ULN at the End of Week 18 (Period 3)

The percentage of patients who achieve ALP of \<1.5 x ULN at the end of week 18 (Period 3)

Time frame:
Week 12 to Week 18
Reported as:
Count of participants · Participants
Percentage of Patients Who Achieve ALP of <1.5 x ULN at the End of Week 18 (Period 3)
ParticipantsHTD1801 500 mg BID to HTD1801 500 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BIDHTD1801 500 mg BID to PlaceboHTD1801 1000 mg BID to Placebo
Percentage of Patients Who Achieve ALP of <1.5 x ULN at the End of Week 18 (Period 3)1401
SecondaryPercentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 18 (Period 3)
Time frame:
Week 12 to Week 18
Reported as:
Count of participants · Participants
Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 18 (Period 3)
ParticipantsHTD1801 500 mg BID to HTD1801 500 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BIDHTD1801 500 mg BID to PlaceboHTD1801 1000 mg BID to Placebo
Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 18 (Period 3)1001
SecondaryPercentage of Subjects Who Normalize ALP at the End of Week 18 (Period 3)
Time frame:
Week 12 to Week 18
Reported as:
Count of participants · Participants
Percentage of Subjects Who Normalize ALP at the End of Week 18 (Period 3)
ParticipantsHTD1801 500 mg BID to HTD1801 500 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BIDHTD1801 500 mg BID to PlaceboHTD1801 1000 mg BID to Placebo
Percentage of Subjects Who Normalize ALP at the End of Week 18 (Period 3)0100
SecondaryAbsolute Change in Serum Total Bilirubin at the End of Week 18 (Period 3)
Time frame:
Week 12 to Week 18
Reported as:
Mean · mg/dL
Absolute Change in Serum Total Bilirubin at the End of Week 18 (Period 3)
mg/dLHTD1801 500 mg BID to HTD1801 500 mg BIDHTD1801 1000 mg BID to HTD1801 1000 mg BIDHTD1801 500 mg BID to PlaceboHTD1801 1000 mg BID to Placebo
Absolute Change in Serum Total Bilirubin at the End of Week 18 (Period 3)-0.2 ± 0.190.0 ± 0.230.1 ± 0.360.1 ± 0.22

Adverse events

Collected over Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
500mg HTD1801 Bid0/22 (0%)1/22 (4.5%)14/22 (63.6%)
1000mg HTD1801 Bid0/31 (0%)3/31 (9.7%)20/31 (64.5%)
Placebo Bid0/35 (0%)0/35 (0%)18/35 (51.4%)
Most frequent serious events
Most frequent serious events
Event500mg HTD1801 Bid1000mg HTD1801 BidPlacebo Bid
Joint InjuryInjury, poisoning and procedural complications1/220/310/35
Stoma site haemorrhageInjury, poisoning and procedural complications0/221/310/35
Intestinal obstructionGastrointestinal disorders0/221/310/35
Clostridium difficile colitisInfections and infestations0/221/310/35
Most frequent other events
Showing 10 of 82
Most frequent other events
Event500mg HTD1801 Bid1000mg HTD1801 BidPlacebo Bid
DiarrhoeaGastrointestinal disorders0/227/310/35
PruritusSkin and subcutaneous tissue disorders2/225/312/35
Blood Alkaline Phosphatase IncreasedInvestigations0/220/315/35
NauseaGastrointestinal disorders0/224/310/35
NasopharyngitisInfections and infestations0/223/312/35
PyrexiaGeneral disorders2/222/311/35
Influenza Like IllnessGeneral disorders2/221/310/35
Alanine Aminotransferase IncreasedInvestigations0/220/313/35
Aspartate Aminotransferase IncreasedInvestigations0/220/313/35
Gamma-Glutamyltransferase IncreasedInvestigations0/220/313/35

Baseline characteristics

A total of 59 subjects were randomized into the study, 55 subjects were included in the safety population and 54 subjects were included in the modified intent-to-treat population (mITT). Four subjects were randomized but did not get study drug - two subjects were not started on study drug because of COVID-19, one subject did not meet eligibility criteria and one subject withdrew consent.

Age, Continuous
Age, Continuous(years)HTD1801 500 mg BIDHTD1801 1000 mg BIDPlacebo BIDTotal
Mean43 ± 13.645 ± 13.740 ± 15.843 ± 14.2
Sex: Female, Male
Sex: Female, Male(Participants)HTD1801 500 mg BIDHTD1801 1000 mg BIDPlacebo BIDTotal
Female410923
Male1114732
Race (NIH/OMB)
Race (NIH/OMB)(Participants)HTD1801 500 mg BIDHTD1801 1000 mg BIDPlacebo BIDTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American1427
White14191346
More than one race0000
Unknown or Not Reported0112
08

Study locations

26 sites
  • Arizona Liver Health
    Chandler, Arizona 85224, United States
  • Arizona Liver Health
    Tuscon, Arizona 85711, United States
  • Fresno Clinical Research Center
    Fresno, California 93720, United States
  • Keck School of Medicine of USC
    Los Angeles, California 90033, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • University of Colorado, Denver
    Aurora, Colorado 80045, United States
  • South Denver Gastroenterology, PC
    Englewood, Colorado 80113, United States
  • Yale School of Medicine
    New Haven, Connecticut 06520, United States
  • Florida Research Institute
    Lakewood Rch, Florida 34211, United States
  • University of Miami
    Miami, Florida 33136, United States
  • Mercy Medical Center
    Baltimore, Maryland 21202, United States
  • Walter Reed National Military Medical Center
    Bethesda, Maryland 20889, United States
  • Michigan Medicine University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Gastrointestinal Associates
    Flowood, Mississippi 39232, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Mount Sinai - Icahn School of Medicine
    New York, New York 10029, United States
  • Cumberland Research Associates
    Fayetteville, North Carolina 28304, United States
  • Wake Forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
  • Gastro One
    Germantown, Tennessee 38138, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
  • Pinnacle Clinical Research
    Austin, Texas 78746, United States
  • Pinnacle Clinical Research
    San Antonio, Texas 78229, United States
  • Swedish Medical Center
    Seattle, Washington 98104, United States
  • University of Washington
    Seattle, Washington 98104, United States
  • Aspen Woods Clinic
    Calgary, Alberta T3H 0V5, Canada
  • Toronto Centre for Liver Disease, Toronto General Hospital
    Toronto, Ontario M5G 2C4, Canada
09

References and documents

Publications

  • Kowdley KV, Forman L, Eksteen B, Gunn N, Sundaram V, Landis C, Harrison SA, Levy C, Liberman A, Di Bisceglie AM, Hirschfield GM. A Randomized, Dose-Finding, Proof-of-Concept Study of Berberine Ursodeoxycholate in Patients With Primary Sclerosing Cholangitis. Am J Gastroenterol. 2022 Nov 1;117(11):1805-1815. doi: 10.14309/ajg.0000000000001956. Epub 2022 Aug 22. PubMed 36327436 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03333928
Lead sponsor
HighTide Therapeutics (Hong Kong) Limited
Responsible party
Sponsor
First posted
Nov 7, 2017
Start date
Feb 9, 2018
Primary completion
Apr 30, 2020
Completion
Aug 14, 2020
Results posted
Apr 6, 2022
Last update
Aug 25, 2026

Study contacts

Adrian Di Bisceglie, MD,FACP,FAASLD
study director · HighTide Therapeutics USA, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Berberine ursodeoxycholate

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