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| Name | Class |
|---|---|
| CTI Clinical Trial and Consulting Services | OTHER |
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This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (Moderate AH) DUR-928 30 mg | Experimental | Lowest dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg |
|
| Part A (Moderate AH) DUR-928 90 mg | Experimental | Middle dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg |
|
| Part A (Moderate AH) DUR-928 150 mg | Experimental | Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg |
|
| Part B (Severe AH) DUR-928 30 mg | Experimental | Lowest dose of dose escalation arms: 30mg, 90 mg and 150 mg |
|
| Part B (Severe AH) DUR-928 90 mg | Experimental | Middle dose of dose escalation arms: 30mg, 90 mg and 150 mg |
|
| Part B (Severe AH) DUR-928 150 mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DUR-928 30 mg | Drug | Lowest dose of 3 dose escalation arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lille Model for Alcoholic Hepatitis Score | The Lille score predicts response of AH subjects to treatment with glucocorticoids, such as prednisolone. This score is based on age, serum albumin, creatinine, PT, and the difference in bilirubin between pre-treatment and Day 7 post-treatment. The Lille score ranges from 0.01 to 1.00. A score >0.45 predicts a higher risk of death and the recommendation to stop steroid administration. Lille Score = Exp(-R)/(1 + Exp(-R)) Where: R = [3.19 - (0.101 x Age in years)] + (1.47 x Albumin in g/dL) + [0.28215 x (Bilirubin initial - Bilirubin day 7 in mg/dL)] - (0.206 x Creatinine in mg/dL) - (0.11115 x Bilirubin initial in mg/dL) - (0.0096 x PT in seconds) NOTE: When calculating Lille, use "baseline" values for ALL parameters EXCEPT bilirubin at Day 7. Baseline would be the Day 1 Pre-dose sample result, if available. If not available, then use the Screening sample result. | Day 7 |
| Model for End Stage Liver Disease (MELD) Score | The MELD score at enrollment is a good predictor for AH patient prognosis. Laboratory values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. The MELD score ranges from 6.0 to 40.0 (capped) with a higher score predicting a higher risk of death. A sequentially improving MELD score is associated with a better chance of recovery. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1. | Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28 |
| Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline | The MELD Score %change from baseline is a %change between 2 time points, baseline and value at a specific time point (Day 7 or Day 28). MELD score is a good predictor of outcome. A declining MELD score suggests disease improvement. Lab values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Cytokeratin 18 (M30) | Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose. | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 |
| Serum Cytokeratin 18 (M65) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine (sCR) | Serum Creatinine (sCR) at baseline is provided as part of the calculation for MELD | Baseline (Screening or Day 1 Pre-dose) |
Inclusion Criteria:
Able to provide written informed consent (either from patient or patient's legally acceptable representative)
Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2
Patients with alcoholic hepatitis defined as:
No evidence of active infection as determined by the investigator.
Women of child-bearing potential must utilize appropriate birth control throughout the study duration.
Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration
Exclusion Criteria:
Other or concomitant cause(s) of liver disease as a result of:
Co-infection with human immunodeficiency virus (HIV) or Hepatitis B
Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
If female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding
Serum creatinine > 2.5 mg/dL
Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant
Stage 3 or greater encephalopathy by West Haven criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert Gordon, MD | CTI Clinical Trial and Consulting Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DURECT Study Site 0001 | San Diego | California | 92118 | United States | ||
| DURECT Study Site 007 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37011138 | Derived | Hassanein T, McClain CJ, Vatsalya V, Stein LL, Flamm SL, Martin P, Cave MC, Mitchell M Jr, Barton B, Nagy L, Szabo G, McCullough A, Dasarathy S, Shah J, Blevins C, Scott D, Krebs W, Brown JE, Lin W. Safety, Pharmacokinetics, and Efficacy Signals of Larsucosterol (DUR-928) in Alcohol-Associated Hepatitis. Am J Gastroenterol. 2024 Jan 1;119(1):107-115. doi: 10.14309/ajg.0000000000002275. Epub 2023 Apr 3. |
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Part A (Moderate AH) and Part B (Severe AH) were assigned treatments in a dose escalation, staggered parallel design.
Part A (Moderate AH) highest dose of dose escalation arms (150 mg) was not enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate AH DUR-928 30 mg | Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll) |
| FG001 | Moderate AH DUR-928 90 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 19, 2018 |
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Staggered parallel design.
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Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg
|
| DUR-928 90 mg | Drug | Middle dose of 3 dose escalation arms. |
|
| DUR-928 150 mg | Drug | Highest dose of 3 dose escalation arms. |
|
| Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28 |
Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose. |
| Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 |
| International Normalized Ratio (INR) - Percent Change From Baseline | ITT population. INR (international normalized ratio) is a standardized number based on the prothrombin time and calculated by the clinical lab. INR measures the time it takes for blood to clot in vitro and measures, among other things, liver synthetic function. | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 |
| Bilirubin - Percent Change From Baseline | ITT population | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 |
| Miami |
| Florida |
| 33136 |
| United States |
| DURECT Study Site 0004 | Atlanta | Georgia | 30309 | United States |
| DURECT Study Site 0002 | Chicago | Illinois | 60611 | United States |
| DURECT Study Site 008 | Indianapolis | Indiana | 46202 | United States |
| DURECT Study Site 0005 | Louisville | Kentucky | 40202 | United States |
| DURECT Study Site 006 | San Antonio | Texas | 78215 | United States |
Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)
| FG002 | Severe AH DUR-928 30 mg | Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| FG003 | Severe AH DUR-928 90 mg | Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| FG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate AH DUR-928 30 mg | Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll) |
| BG001 | Moderate AH DUR-928 90 mg | Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll) |
| BG002 | Severe AH DUR-928 30 mg | Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| BG003 | Severe AH DUR-928 90 mg | Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| BG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Lille Model for Alcoholic Hepatitis Score | The Lille score predicts response of AH subjects to treatment with glucocorticoids, such as prednisolone. This score is based on age, serum albumin, creatinine, PT, and the difference in bilirubin between pre-treatment and Day 7 post-treatment. The Lille score ranges from 0.01 to 1.00. A score >0.45 predicts a higher risk of death and the recommendation to stop steroid administration. Lille Score = Exp(-R)/(1 + Exp(-R)) Where: R = [3.19 - (0.101 x Age in years)] + (1.47 x Albumin in g/dL) + [0.28215 x (Bilirubin initial - Bilirubin day 7 in mg/dL)] - (0.206 x Creatinine in mg/dL) - (0.11115 x Bilirubin initial in mg/dL) - (0.0096 x PT in seconds) NOTE: When calculating Lille, use "baseline" values for ALL parameters EXCEPT bilirubin at Day 7. Baseline would be the Day 1 Pre-dose sample result, if available. If not available, then use the Screening sample result. | ITT | Posted | Median | Full Range | score on a scale | Day 7 |
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| |||||||||||||||||||||||||||||||||||||
| Primary | Model for End Stage Liver Disease (MELD) Score | The MELD score at enrollment is a good predictor for AH patient prognosis. Laboratory values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. The MELD score ranges from 6.0 to 40.0 (capped) with a higher score predicting a higher risk of death. A sequentially improving MELD score is associated with a better chance of recovery. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1. | ITT, baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose | Posted | Median | Full Range | score on a scale | Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline | The MELD Score %change from baseline is a %change between 2 time points, baseline and value at a specific time point (Day 7 or Day 28). MELD score is a good predictor of outcome. A declining MELD score suggests disease improvement. Lab values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1. | ITT | Posted | Median | Full Range | Percent Change | Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28 |
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| Secondary | Serum Cytokeratin 18 (M30) | Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose. | Number analyzed is dependent on samples being collected and evaluable. | Posted | Median | Full Range | U/L | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 |
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| Secondary | Serum Cytokeratin 18 (M65) | Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose. | Number analyzed is dependent on samples being collected and evaluable. | Posted | Median | Full Range | U/L | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 |
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| Secondary | International Normalized Ratio (INR) - Percent Change From Baseline | ITT population. INR (international normalized ratio) is a standardized number based on the prothrombin time and calculated by the clinical lab. INR measures the time it takes for blood to clot in vitro and measures, among other things, liver synthetic function. | Baseline is defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose | Posted | Median | Full Range | Percent Change | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 |
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| Secondary | Bilirubin - Percent Change From Baseline | ITT population | Baseline is defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose | Posted | Median | Full Range | Percent Change | Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28 |
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| Other Pre-specified | Serum Creatinine (sCR) | Serum Creatinine (sCR) at baseline is provided as part of the calculation for MELD | Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose. | Posted | Median | Full Range | mg/dL | Baseline (Screening or Day 1 Pre-dose) |
|
28 days
If subject was not available in person, they were contacted via phone.
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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 | Moderate AH DUR-928 30 mg | Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll) | 0 | 4 | 2 | 4 | 4 | 4 |
| EG001 | Moderate AH DUR-928 90 mg | Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll) | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | Severe AH DUR-928 30 mg | Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg | 0 | 4 | 2 | 4 | 3 | 4 |
| EG003 | Severe AH DUR-928 90 mg | Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg | 0 | 4 | 1 | 4 | 3 | 4 |
| EG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg | 0 | 4 | 0 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hematemesis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Weight increased | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
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| Renal pain | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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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 120-180 days after submission to sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | DURECT Corporation | 408-777-1418 | jill.burns@durect.com |
| Nov 18, 2022 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg
DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)
| OG002 | Severe AH DUR-928 30 mg | Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| OG003 | Severe AH DUR-928 90 mg | Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| OG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
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| OG002 | Severe AH DUR-928 30 mg | Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| OG003 | Severe AH DUR-928 90 mg | Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| OG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
|
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Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg
DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg
| OG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
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Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg
DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg
| OG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
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| OG003 |
| Severe AH DUR-928 90 mg |
Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
| OG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
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| OG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
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| OG004 | Severe AH DUR-928 150 mg | Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg DUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg |
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