A Phase 2 interventional study of DUR-928 30 mg and DUR-928 90 mg in Alcoholic Hepatitis, sponsored by Durect. Completed at 7 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Durect (part of Bausch Health Companies Inc.) · Phase 2, Interventional, and Treatment
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).
113 studies on the registry are indexed under Hepatitis, Alcoholic; 24 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 80 interventional studies indexed under Hepatitis, Alcoholic.
Browse Hepatitis, Alcoholic studies →Durect is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
First submitted before Durect became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
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.
Patients with alcoholic hepatitis defined as:
Exclusion Criteria:
Other or concomitant cause(s) of liver disease as a result of:
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lowest dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg
Drug: DUR-928 30 mg
Middle dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg
Drug: DUR-928 90 mg
Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg
Drug: DUR-928 150 mg
Lowest dose of dose escalation arms: 30mg, 90 mg and 150 mg
Drug: DUR-928 30 mg
Middle dose of dose escalation arms: 30mg, 90 mg and 150 mg
Drug: DUR-928 90 mg
Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg
Drug: DUR-928 150 mg
Lowest dose of 3 dose escalation arms.
Middle dose of 3 dose escalation arms.
Highest dose of 3 dose escalation arms.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28
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.
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28
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.
Time frame: 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.
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28
Bilirubin - Percent Change From Baseline
ITT population
Time frame: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28
Serum Creatinine (sCR)
Serum Creatinine (sCR) at baseline is provided as part of the calculation for MELD
Time frame: Baseline (Screening or Day 1 Pre-dose)
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.
| Milestone | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| Started | 4 | 3 | 4 | 4 | 4 |
| Completed | 3 | 2 | 4 | 4 | 3 |
| Not completed | 1 | 1 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 | 0 | 1 |
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.
| score on a scale | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| Lille Model for Alcoholic Hepatitis Score | 0.020 (0.01 to 0.04) | 0.050 (0.01 to 0.05) | 0.155 (0.05 to 0.19) | 0.195 (0.04 to 0.24) | 0.420 (0.08 to 0.87) |
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.
| score on a scale | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| Screening | 19.5 (15 to 20) | 19.0 (14 to 21) | 24.5 (21 to 28) | 24.5 (21 to 28) | 25.0 (23 to 27) |
| Day 1 Pre-dose | — | 20.0 (20 to 20) | 23.0 (21 to 26) | 24.0 (24 to 24) | 23.0 (21 to 26) |
| Day 7 | 17.0 (16 to 19) | 17.0 (11 to 19) | 23.5 (21 to 29) | 24.0 (21 to 29) | 24.0 (21 to 28) |
| Day 28 | 15.0 (12 to 20) | 11.5 (8 to 15) | 19.0 (16 to 24) | 23.5 (17 to 28) | 23.0 (19 to 29) |
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.
| Percent Change | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| Day 7 | -5.00 (-10.5 to 6.7) | -10.53 (-21.4 to -5.0) | 0.00 (-8.7 to 3.6) | 0.00 (-4.0 to 3.6) | 0.00 (-4.3 to 3.7) |
| Day 28 | -20.00 (-21.1 to 0.00) | -33.93 (-42.9 to -25.0) | -26.76 (-35.7 to 14.3) | -8.00 (-19.0 to 8.3) | 0.00 (-29.6 to 11.5) |
Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.
| U/L | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| Day 1-Predose | 723.5 (334 to 2255) | 737 (467 to 4000) | 1443.5 (561 to 4000) | 1946 (292 to 4000) | 931 (752 to 1766) |
| Day 7 | 526 (257 to 3150) | 3112 (2124 to 3440) | 3305.5 (500 to 4000) | 1702.0 (323 to 4000) | 1012.5 (439 to 4000) |
| Day 28 | — | 2205.5 (411 to 4000) | 1114.0 (612 to 3160) | 550.5 (243 to 4000) | 161.0 (108 to 4000) |
Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.
| U/L | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| Day 1-Predose | 252.5 (217 to 2074) | 1791.0 (729 to 14208) | 3033.5 (750 to 20000) | 4071.5 (225 to 20000) | 1999.0 (1777 to 2209) |
| Day 7 | 353.0 (119 to 3029) | 4697.0 (4416 to 9928) | 7303.0 (709 to 20000) | 4397.5 (234 to 20000) | 3994.5 (502 to 15028) |
| Day 28 | — | 4771.5 (807 to 8736) | 2426.0 (998 to 7420) | 1224.5 (224 to 17232) | 1987.0 (452 to 3246) |
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.
| Percent Change | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| Day 7 Percent Change from Baseline | -10.000 (-11.11 to 7.35) | -3.226 (-8.33 to 7.14) | 4.768 (-8.88 to 10.53) | 0.000 (-5.26 to 43.75) | 0.000 (-8.33 to 6.67) |
| Day 28 Percent Change from Baseline | -3.676 (-22.22 to 0.00) | 0.000 (0.00 to 0.00) | -19.402 (-29.68 to 17.65) | -3.180 (-21.05 to 18.75) | 0.000 (-33.33 to 42.11) |
ITT population
| Percent Change | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| Day 7 Percent Change from Baseline | -15.69 (-34.5 to 17.1) | -31.03 (-43.9 to -29.3) | -25.19 (-49.8 to -9.0) | -6.48 (-25.1 to 6.6) | 4.96 (-29.3 to 24.7) |
| Day 28 Percent Change from Baseline | -27.27 (-40.0 to -5.9) | -74.27 (-75.6 to -72.9) | -56.93 (-74.1 to 34.0) | -34.82 (-47.9 to 50.0) | -10.04 (-63.6 to 1.5) |
Serum Creatinine (sCR) at baseline is provided as part of the calculation for MELD
| mg/dL | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| Baseline (Screening) | 0.620 (0.46 to 0.80) | 0.710 (0.2 to 0.84) | 0.795 (0.63 to 1.20) | 0.765 (0.59 to 1.50) | 0.610 (0.50 to 1.00) |
| Baseline (Day 1-Pre dose) | — | 0.660 (0.66 to 0.66) | 0.640 (0.61 to 0.78) | 0.580 (0.58 to 0.58) | 0.520 (0.50 to 0.70) |
Collected over 28 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate AH DUR-928 30 mg | 0/4 (0%) | 2/4 (50%) | 4/4 (100%) |
| Moderate AH DUR-928 90 mg | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Severe AH DUR-928 30 mg | 0/4 (0%) | 2/4 (50%) | 3/4 (75%) |
| Severe AH DUR-928 90 mg | 0/4 (0%) | 1/4 (25%) | 3/4 (75%) |
| Severe AH DUR-928 150 mg | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Event | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 1/4 | 0/3 | 0/4 | 0/4 | 0/4 |
| Abdominal painGastrointestinal disorders | 0/4 | 0/3 | 1/4 | 0/4 | 0/4 |
| AscitesGastrointestinal disorders | 1/4 | 0/3 | 0/4 | 1/4 | 0/4 |
| HematemesisGastrointestinal disorders | 0/4 | 0/3 | 1/4 | 0/4 | 0/4 |
| Fluid overloadMetabolism and nutrition disorders | 0/4 | 0/3 | 1/4 | 0/4 | 0/4 |
| HypokalemiaMetabolism and nutrition disorders | 0/4 | 0/3 | 0/4 | 1/4 | 0/4 |
| HeadacheNervous system disorders | 0/4 | 0/3 | 0/4 | 1/4 | 0/4 |
| Event | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 1/4 | 0/3 | 1/4 | 0/4 | 2/4 |
| DiarrhoeaGastrointestinal disorders | 0/4 | 0/3 | 2/4 | 0/4 | 0/4 |
| Food poisoningGastrointestinal disorders | 0/4 | 1/3 | 0/4 | 0/4 | 0/4 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/4 | 1/3 | 0/4 | 0/4 | 0/4 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/4 | 1/3 | 0/4 | 0/4 | 0/4 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 0/4 | 1/3 | 0/4 | 0/4 | 0/4 |
| DehydrationMetabolism and nutrition disorders | 0/4 | 0/3 | 0/4 | 1/4 | 0/4 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/4 | 0/3 | 0/4 | 1/4 | 0/4 |
| HyperkalaemiaMetabolism and nutrition disorders | 1/4 | 0/3 | 0/4 | 0/4 | 0/4 |
| InsomniaPsychiatric disorders | 0/4 | 0/3 | 1/4 | 1/4 | 1/4 |
| Age, Continuous(years) | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg | Total |
|---|---|---|---|---|---|---|
| Median | 36.5 (33.0 to 39.5) | 42.0 (33.0 to 43.0) | 45.0 (37.5 to 52.5) | 43.5 (40.0 to 45.0) | 40.5 (35.5 to 46.0) | 41.0 (35.0 to 45.0) |
| Sex: Female, Male(Participants) | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 1 | 1 | 1 | 2 | 8 |
| Male | 1 | 2 | 3 | 3 | 2 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 2 | 2 | 2 | 7 |
| Not Hispanic or Latino | 3 | 3 | 2 | 2 | 2 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 0 | 1 |
| Black or African American | 0 | 0 | 0 | 0 | 1 | 1 |
| White | 3 | 3 | 4 | 4 | 3 | 17 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Moderate AH DUR-928 30 mg | Moderate AH DUR-928 90 mg | Severe AH DUR-928 30 mg | Severe AH DUR-928 90 mg | Severe AH DUR-928 150 mg | Total |
|---|---|---|---|---|---|---|
| United States | 4 | 3 | 4 | 4 | 4 | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Sep 2019, 16 months.
Results were first posted in Dec 2022, 3 years 3 months after primary completion. A results delay was requested in Oct 2020.
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Larsucosterol