Trial · NCT03333928
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
NCT03333928, Phase 2, Completed, HighTide Therapeutics (Hong Kong) Limited; results first posted 2022-04-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A POC and Dose-Ranging Study of HTD1801 in PSC Patients. Trials, record NCT03333928. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03333928
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A POC and Dose-Ranging Study of HTD1801 in PSC Patients
- NCT number
- NCT03333928
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- HighTide Therapeutics (Hong Kong) Limited
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Interventions
- HTD1801, Placebo
- First posted
- 2017-11-07
- Last updated
- 2026-08-25
- Results first posted
- 2022-04-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1 | Baseline to Week 6 | |
| Secondary | Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1) | Baseline to Week 6 | |
| Secondary | Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1) | Baseline to Week 6 | |
| Secondary | Percentage of Subjects Who Normalize ALP at the End of Week 6 (Period 1) | Baseline to Week 6 | |
| Secondary | Absolute Change in Serum Total Bilirubin at the End of Week 6 (Period 1) | Baseline to Week 6 | |
| Secondary | Absolute Change in Serum ALP From Week 6 to Week 12 (Period 2) | Week 6 to Week 12 | |
| Secondary | Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 12 (Period 2) | Week 6 to Week 12 | |
| Secondary | Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 12 (Period 2) | Week 6 to Week 12 | |
| Secondary | Percentage of Patients Who Normalize ALP at the End of Week 12 (Period 2) | Week 6 to Week 12 | |
| Secondary | Absolute Change in Serum Total Bilirubin at the End of Week 12 (Period 2) | Week 6 to Week 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1 | Baseline to Week 6 | Modified Intent-to-Treat (mITT) population: 59 subjects were randomized; however, 4 subjects did not receive the study drug. The remaining 55 subjects were dosed with study drug; however, 1 subject was excluded due to the absence of baseline assessments and withdrew due to AE on Day 2. The mITT population consisted of the remaining 54 subjects. Subjects were randomized to receive HTD1801 BID doses of 500 mg, 1000 mg, or matching placebo for 6 weeks. | U/L | MEAN |
| SECONDARY | Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1) | Baseline to Week 6 | Period 1 mITT population: 54 subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1) | Baseline to Week 6 | Period 1 mITT population: 54 subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects Who Normalize ALP at the End of Week 6 (Period 1) | Baseline to Week 6 | Period 1 mITT population: 54 subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Change in Serum Total Bilirubin at the End of Week 6 (Period 1) | Baseline to Week 6 | Period 1 mITT population: 54 subjects. | mg/dL | MEAN |
| SECONDARY | Absolute Change in Serum ALP From Week 6 to Week 12 (Period 2) | Week 6 to Week 12 | Subjects previously randomized in Period 1 to HTD1801 500 mg BID or HTD1801 1000 mg BID continued for 6 more weeks at that previous dose, while subjects previously randomized to placebo were re-randomized to receive 6 weeks of either HTD1801 500 mg BID or HTD1801 1000 mg BID. 51 subjects in the mITT population started Period 2. 49 subjects in the mITT population completed Period 2. | U/L | MEAN |
| SECONDARY | Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 12 (Period 2) | Week 6 to Week 12 | 51 subjects in the mITT population who completed Period 1 and began Period 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 12 (Period 2) | Week 6 to Week 12 | 51 subjects in the mITT population who completed Period 1 and began Period 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Who Normalize ALP at the End of Week 12 (Period 2) | Week 6 to Week 12 | 51 subjects in the mITT population who completed Period 1 and began Period 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Change in Serum Total Bilirubin at the End of Week 12 (Period 2) | Week 6 to Week 12 | 49 subjects in the mITT population who completed Period 2. | mg/dL | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1 | HTD1801 500 mg BID | -71 | Standard Error 136.9 | U/L | |
| Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1 | HTD1801 1000 mg BID | -73 | Standard Error 139.9 | U/L | |
| Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1 | Placebo BID | 94 | Standard Error 261.7 | U/L | |
| Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1) | HTD1801 500 mg BID | 2 | Participants | ||
| Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1) | HTD1801 1000 mg BID | 6 | Participants | ||
| Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1) | Placebo BID | 1 | Participants | ||
| Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1) | HTD1801 500 mg BID | 1 | Participants | ||
| Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1) | HTD1801 1000 mg BID | 4 | Participants | ||
| Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1) | Placebo BID | 0 | Participants | ||
| Percentage of Subjects Who Normalize ALP at the End of Week 6 (Period 1) | HTD1801 500 mg BID | 0 | Participants |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Dosing Period (Period 1) | STARTED | 500mg HTD1801 BID | 16 | |
| Initial Dosing Period (Period 1) | STARTED | 1000 mg HTD1801 BID | 25 | |
| Initial Dosing Period (Period 1) | STARTED | Placebo BID | 18 | |
| Initial Dosing Period (Period 1) | COMPLETED | 500mg HTD1801 BID | 15 | |
| Initial Dosing Period (Period 1) | COMPLETED | 1000 mg HTD1801 BID | 21 | |
| Initial Dosing Period (Period 1) | COMPLETED | Placebo BID | 14 | |
| Initial Dosing Period (Period 1) | NOT COMPLETED | 500mg HTD1801 BID | 1 | |
| Initial Dosing Period (Period 1) | NOT COMPLETED | 1000 mg HTD1801 BID | 4 | |
| Initial Dosing Period (Period 1) | NOT COMPLETED | Placebo BID | 4 | |
| Dose-controlled Extension (Period 2) | STARTED | 500mg HTD1801 BID | 22 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events258
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | 500mg HTD1801 bid | 0 | 22 | |
| other | Diarrhoea | Gastrointestinal disorders | 1000mg HTD1801 bid | 7 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | placebo bid | 0 | 35 | |
| other | Nausea | Gastrointestinal disorders | 500mg HTD1801 bid | 0 | 22 | |
| other | Nausea | Gastrointestinal disorders | 1000mg HTD1801 bid | 4 | 31 | |
| other | Nausea | Gastrointestinal disorders | placebo bid | 0 | 35 | |
| other | Abdominal pain | Gastrointestinal disorders | 500mg HTD1801 bid | 1 | 22 | |
| other | Abdominal pain | Gastrointestinal disorders | 1000mg HTD1801 bid | 1 | 31 | |
| other | Abdominal pain | Gastrointestinal disorders | placebo bid | 1 | 35 | |
| other | Abdominal pain upper | Gastrointestinal disorders | 500mg HTD1801 bid | 1 | 22 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 500mg HTD1801 bid | 0 | 22 |
| Total, all-cause mortality | 1000mg HTD1801 bid | 0 | 31 |
| Total, all-cause mortality | placebo bid | 0 | 35 |
| Total, other adverse events | 500mg HTD1801 bid | 14 | 22 |
| Total, other adverse events | 1000mg HTD1801 bid | 20 | 31 |
| Total, other adverse events | placebo bid | 18 | 35 |
| Total, serious adverse events | 500mg HTD1801 bid | 1 | 22 |
| Total, serious adverse events | 1000mg HTD1801 bid | 3 | 31 |
| Total, serious adverse events | placebo bid | 0 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36327436 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03333928
GET https://conductscience.org/api/trials/v1/NCT03333928/results?page=2