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poor enrollment
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This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DUR-928 10 mg | Experimental | 10 mg oral suspension |
|
| DUR-928 50 mg | Experimental | 50 mg oral suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DUR-928 | Drug | oral suspension daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Alkaline Phosphatase (ALP) From Baseline | Day 28 (end of treatment) and Day 56 (end of study/early termination) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | 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). | Day 28 and Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alastair Smith, MD | INC Research/InVentiv Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center | San Francisco | California | 94115 | United States | ||
| Mayo Clinic Florida |
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Study was terminated early due to lack of enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | DUR-928 10 mg | 10 mg oral suspension DUR-928: oral suspension daily for 28 days |
| FG001 | DUR-928 50 mg | 50 mg oral suspension DUR-928: oral suspension daily for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DUR-928 10 mg | 10 mg oral suspension DUR-928: oral suspension daily for 28 days |
| BG001 | DUR-928 50 mg | 50 mg oral suspension DUR-928: oral suspension daily for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change of Alkaline Phosphatase (ALP) From Baseline | Posted | Mean | Standard Deviation | percent change | Day 28 (end of treatment) and Day 56 (end of study/early termination) |
|
|
56 days
Treatment Emergent Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DUR-928 10 mg | 10 mg oral suspension DUR-928: oral suspension daily for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRUG INDUCED LIVER INJURY | Hepatobiliary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director, Regulatory Affairs | DURECT Corporation | 408-777-1829 | jill.burns@durect.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2018 | Aug 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline |
| Day 28 (end of treatment) and Day 56 (end of follow-up) |
| Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period. | Day 28 and Day 56 |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Southern Therapy and Advanced Research | Jackson | Mississippi | 39216 | United States |
| Charlotte Mecklenburg Hospital | Charlotte | North Carolina | 28203 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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|
|
| Secondary | Percent Change of Liver Enzymes and Serum Bile Acids (sBA) | 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). | Study terminated early due to lack of enrollment. | Posted | Mean | Standard Deviation | percent change | Day 28 and Day 56 |
|
|
|
| Secondary | Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline | Posted | Count of Participants | Participants | 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. | The samples were not assayed to generate data for this Outcome Measure due to early study termination. | Posted | Day 28 and Day 56 |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | DUR-928 50 mg | 50 mg oral suspension DUR-928: oral suspension daily for 28 days | 0 | 2 | 0 | 2 | 1 | 2 |
| WORSENING SINUS BRADYCARDIA | Cardiac disorders | Non-systematic Assessment |
|
| EXCESSIVE GAS (FLATUS) | Gastrointestinal disorders | Non-systematic Assessment |
|
| ELEVATED ALKALINE PHOSPHATASE | Investigations | Non-systematic Assessment |
|
| ELEVATED ALT | Investigations | Non-systematic Assessment |
|
| ELEVATED AST | Investigations | Non-systematic Assessment |
|
| ELEVATED GGT | Investigations | Non-systematic Assessment |
|
| ELEVATED SERUM BILE ACIDS | Investigations | Non-systematic Assessment |
|
| LEFT EAR ERYTHEMA PRESENT | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
If a joint publication is not submitted within 18-24 months after study completion, PI shall have the right to submit to sponsor a proposed results communication based on results at their institution. Sponsor can review proposed results communications prior to public release, can request removal of confidential information, and can embargo communications regarding trial results for up to 105-120 days after submission to sponsor.
| percent AST change from baseline to Day 28 |
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| percent GGT change from baseline to Day 28 |
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| percent direct bilirubin change from baseline to Day 28 |
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| percent total bilirubin change from baseline to Day 28 |
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| percent serum bile acids change from baseline to Day 28 |
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| percent ALT change from baseline to Day 56 |
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| percent AST change from baseline to Day 56 |
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| percent GGT change from baseline to Day 56 |
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| percent direct bilirubin change from baseline to Day 56 |
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| percent total bilirubin change from baseline to Day 56 |
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| percent serum bile acids change from baseline to Day 56 |
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