Trial · NCT03394781
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
NCT03394781, Phase 2, Terminated, Durect; results first posted 2022-10-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC). Trials, record NCT03394781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03394781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
- NCT number
- NCT03394781
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Durect
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- DUR-928
- First posted
- 2018-01-09
- Last updated
- 2022-10-17
- Results first posted
- 2022-10-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change of Alkaline Phosphatase (ALP) From Baseline | Day 28 (end of treatment) and Day 56 (end of study/early termination) | |
| Secondary | Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | Day 28 and Day 56 | Liver enzymes include alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), bilirubin. Percent change from baseline through the end of study treatment (Day 28) and throughout the follow-up period (Day 56). |
| Secondary | Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline | Day 28 (end of treatment) and Day 56 (end of follow-up) | |
| Secondary | Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period. | Day 28 and Day 56 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change of Alkaline Phosphatase (ALP) From Baseline | Day 28 (end of treatment) and Day 56 (end of study/early termination) | percent change | MEAN | |
| SECONDARY | Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | Day 28 and Day 56 | Study terminated early due to lack of enrollment. | percent change | MEAN |
| SECONDARY | Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline | Day 28 (end of treatment) and Day 56 (end of follow-up) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period. | Day 28 and Day 56 | The samples were not assayed to generate data for this Outcome Measure due to early study termination. |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change of Alkaline Phosphatase (ALP) From Baseline | DUR-928 10 mg | Percent change of ALP from baseline to Day 28 | 23.7 | Standard Deviation 10.7 | percent change |
| Percent Change of Alkaline Phosphatase (ALP) From Baseline | DUR-928 50 mg | Percent change of ALP from baseline to Day 28 | 16.8 | Standard Deviation 2.97 | percent change |
| Percent Change of Alkaline Phosphatase (ALP) From Baseline | DUR-928 10 mg | Percent change of ALP from baseline to Day 56 | 10.7 | Standard Deviation 17.04 | percent change |
| Percent Change of Alkaline Phosphatase (ALP) From Baseline | DUR-928 50 mg | Percent change of ALP from baseline to Day 56 | 11.05 | Standard Deviation 8.68 | percent change |
| Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | DUR-928 10 mg | percent ALT change from baseline to Day 28 | 32.87 | Standard Deviation 48.87 | percent change |
| Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | DUR-928 50 mg | percent ALT change from baseline to Day 28 | 3.0 | Standard Deviation 29.56 | percent change |
| Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | DUR-928 10 mg | percent AST change from baseline to Day 28 | 24.10 | Standard Deviation 35.03 | percent change |
| Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | DUR-928 50 mg | percent AST change from baseline to Day 28 | -20.25 | Standard Deviation 3.23 | percent change |
| Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | DUR-928 10 mg | percent GGT change from baseline to Day 28 | 7.3 | Standard Deviation 4.16 | percent change |
| Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | DUR-928 50 mg | percent GGT change from baseline to Day 28 | 8.15 | Standard Deviation 1.49 | percent change |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DUR-928 10 mg | 3 | |
| Overall Study | STARTED | DUR-928 50 mg | 2 | |
| Overall Study | COMPLETED | DUR-928 10 mg | 3 | |
| Overall Study | COMPLETED | DUR-928 50 mg | 2 | |
| Overall Study | NOT COMPLETED | DUR-928 10 mg | 0 | |
| Overall Study | NOT COMPLETED | DUR-928 50 mg | 0 |
Source ClinicalTrials.gov
Adverse events18
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 | DRUG INDUCED LIVER INJURY | Hepatobiliary disorders | DUR-928 10 mg | 1 | 3 | 1 |
| other | DRUG INDUCED LIVER INJURY | Hepatobiliary disorders | DUR-928 50 mg | 0 | 2 | 0 |
| other | WORSENING SINUS BRADYCARDIA | Cardiac disorders | DUR-928 10 mg | 1 | 3 | 1 |
| other | WORSENING SINUS BRADYCARDIA | Cardiac disorders | DUR-928 50 mg | 0 | 2 | 0 |
| other | EXCESSIVE GAS (FLATUS) | Gastrointestinal disorders | DUR-928 10 mg | 1 | 3 | 1 |
| other | EXCESSIVE GAS (FLATUS) | Gastrointestinal disorders | DUR-928 50 mg | 0 | 2 | 0 |
| other | ELEVATED ALKALINE PHOSPHATASE | Investigations | DUR-928 10 mg | 0 | 3 | 0 |
| other | ELEVATED ALKALINE PHOSPHATASE | Investigations | DUR-928 50 mg | 1 | 2 | 1 |
| other | ELEVATED ALT | Investigations | DUR-928 10 mg | 0 | 3 | 0 |
| other | ELEVATED ALT | Investigations | DUR-928 50 mg | 1 | 2 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DUR-928 10 mg | 0 | 3 |
| Total, all-cause mortality | DUR-928 50 mg | 0 | 2 |
| Total, other adverse events | DUR-928 10 mg | 2 | 3 |
| Total, other adverse events | DUR-928 50 mg | 1 | 2 |
| Total, serious adverse events | DUR-928 10 mg | 0 | 3 |
| Total, serious adverse events | DUR-928 50 mg | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DUR-928 10 mg vs DUR-928 50 mg: deaths from any cause | Trial comparisons |
| DUR-928 10 mg vs DUR-928 50 mg: serious adverse events | Trial comparisons |
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/NCT03394781
GET https://conductscience.org/api/trials/v1/NCT03394781/results?page=2