Trial Outcomes & Findings for A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis (NCT NCT03432260)
NCT ID: NCT03432260
Last Updated: 2024-09-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Day 7
Results posted on
2024-09-24
Participant Flow
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.
Participant milestones
| Measure |
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)
|
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)
|
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
|
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
|
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
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
2
|
4
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
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
|
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
|
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
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
Baseline characteristics by cohort
| Measure |
Moderate AH DUR-928 30 mg
n=4 Participants
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)
|
Moderate AH DUR-928 90 mg
n=3 Participants
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)
|
Severe AH DUR-928 30 mg
n=4 Participants
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
|
Severe AH DUR-928 90 mg
n=4 Participants
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
|
Severe AH DUR-928 150 mg
n=4 Participants
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
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.5 years
n=5 Participants
|
42.0 years
n=7 Participants
|
45.0 years
n=5 Participants
|
43.5 years
n=4 Participants
|
40.5 years
n=21 Participants
|
41.0 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
19 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: ITT
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.
Outcome measures
| Measure |
Moderate AH DUR-928 30 mg
n=3 Participants
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)
|
Moderate AH DUR-928 90 mg
n=3 Participants
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)
|
Severe AH DUR-928 30 mg
n=4 Participants
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
|
Severe AH DUR-928 90 mg
n=4 Participants
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
|
Severe AH DUR-928 150 mg
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Lille Model for Alcoholic Hepatitis Score
|
0.020 score on a scale
Interval 0.01 to 0.04
|
0.050 score on a scale
Interval 0.01 to 0.05
|
0.155 score on a scale
Interval 0.05 to 0.19
|
0.195 score on a scale
Interval 0.04 to 0.24
|
0.420 score on a scale
Interval 0.08 to 0.87
|
PRIMARY outcome
Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28Population: ITT, baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose
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.
Outcome measures
| Measure |
Moderate AH DUR-928 30 mg
n=4 Participants
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)
|
Moderate AH DUR-928 90 mg
n=3 Participants
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)
|
Severe AH DUR-928 30 mg
n=4 Participants
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
|
Severe AH DUR-928 90 mg
n=4 Participants
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
|
Severe AH DUR-928 150 mg
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Model for End Stage Liver Disease (MELD) Score
Screening
|
19.5 score on a scale
Interval 15.0 to 20.0
|
19.0 score on a scale
Interval 14.0 to 21.0
|
24.5 score on a scale
Interval 21.0 to 28.0
|
24.5 score on a scale
Interval 21.0 to 28.0
|
25.0 score on a scale
Interval 23.0 to 27.0
|
|
Model for End Stage Liver Disease (MELD) Score
Day 1 Pre-dose
|
—
|
20.0 score on a scale
Interval 20.0 to 20.0
|
23.0 score on a scale
Interval 21.0 to 26.0
|
24.0 score on a scale
Interval 24.0 to 24.0
|
23.0 score on a scale
Interval 21.0 to 26.0
|
|
Model for End Stage Liver Disease (MELD) Score
Day 7
|
17.0 score on a scale
Interval 16.0 to 19.0
|
17.0 score on a scale
Interval 11.0 to 19.0
|
23.5 score on a scale
Interval 21.0 to 29.0
|
24.0 score on a scale
Interval 21.0 to 29.0
|
24.0 score on a scale
Interval 21.0 to 28.0
|
|
Model for End Stage Liver Disease (MELD) Score
Day 28
|
15.0 score on a scale
Interval 12.0 to 20.0
|
11.5 score on a scale
Interval 8.0 to 15.0
|
19.0 score on a scale
Interval 16.0 to 24.0
|
23.5 score on a scale
Interval 17.0 to 28.0
|
23.0 score on a scale
Interval 19.0 to 29.0
|
PRIMARY outcome
Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28Population: ITT
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.
Outcome measures
| Measure |
Moderate AH DUR-928 30 mg
n=3 Participants
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)
|
Moderate AH DUR-928 90 mg
n=3 Participants
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)
|
Severe AH DUR-928 30 mg
n=4 Participants
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
|
Severe AH DUR-928 90 mg
n=4 Participants
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
|
Severe AH DUR-928 150 mg
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline
Day 7
|
-5.00 Percent Change
Interval -10.5 to 6.7
|
-10.53 Percent Change
Interval -21.4 to -5.0
|
0.00 Percent Change
Interval -8.7 to 3.6
|
0.00 Percent Change
Interval -4.0 to 3.6
|
0.00 Percent Change
Interval -4.3 to 3.7
|
|
Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline
Day 28
|
-20.00 Percent Change
Interval -21.1 to 0.0
|
-33.93 Percent Change
Interval -42.9 to -25.0
|
-26.76 Percent Change
Interval -35.7 to 14.3
|
-8.00 Percent Change
Interval -19.0 to 8.3
|
0.00 Percent Change
Interval -29.6 to 11.5
|
SECONDARY outcome
Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28Population: Number analyzed is dependent on samples being collected and evaluable.
Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.
Outcome measures
| Measure |
Moderate AH DUR-928 30 mg
n=4 Participants
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)
|
Moderate AH DUR-928 90 mg
n=3 Participants
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)
|
Severe AH DUR-928 30 mg
n=4 Participants
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
|
Severe AH DUR-928 90 mg
n=4 Participants
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
|
Severe AH DUR-928 150 mg
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Serum Cytokeratin 18 (M30)
Day 1-Predose
|
723.5 U/L
Interval 334.0 to 2255.0
|
737 U/L
Interval 467.0 to 4000.0
|
1443.5 U/L
Interval 561.0 to 4000.0
|
1946 U/L
Interval 292.0 to 4000.0
|
931 U/L
Interval 752.0 to 1766.0
|
|
Serum Cytokeratin 18 (M30)
Day 7
|
526 U/L
Interval 257.0 to 3150.0
|
3112 U/L
Interval 2124.0 to 3440.0
|
3305.5 U/L
Interval 500.0 to 4000.0
|
1702.0 U/L
Interval 323.0 to 4000.0
|
1012.5 U/L
Interval 439.0 to 4000.0
|
|
Serum Cytokeratin 18 (M30)
Day 28
|
—
|
2205.5 U/L
Interval 411.0 to 4000.0
|
1114.0 U/L
Interval 612.0 to 3160.0
|
550.5 U/L
Interval 243.0 to 4000.0
|
161.0 U/L
Interval 108.0 to 4000.0
|
SECONDARY outcome
Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28Population: Number analyzed is dependent on samples being collected and evaluable.
Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.
Outcome measures
| Measure |
Moderate AH DUR-928 30 mg
n=4 Participants
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)
|
Moderate AH DUR-928 90 mg
n=3 Participants
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)
|
Severe AH DUR-928 30 mg
n=4 Participants
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
|
Severe AH DUR-928 90 mg
n=4 Participants
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
|
Severe AH DUR-928 150 mg
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Serum Cytokeratin 18 (M65)
Day 1-Predose
|
252.5 U/L
Interval 217.0 to 2074.0
|
1791.0 U/L
Interval 729.0 to 14208.0
|
3033.5 U/L
Interval 750.0 to 20000.0
|
4071.5 U/L
Interval 225.0 to 20000.0
|
1999.0 U/L
Interval 1777.0 to 2209.0
|
|
Serum Cytokeratin 18 (M65)
Day 7
|
353.0 U/L
Interval 119.0 to 3029.0
|
4697.0 U/L
Interval 4416.0 to 9928.0
|
7303.0 U/L
Interval 709.0 to 20000.0
|
4397.5 U/L
Interval 234.0 to 20000.0
|
3994.5 U/L
Interval 502.0 to 15028.0
|
|
Serum Cytokeratin 18 (M65)
Day 28
|
—
|
4771.5 U/L
Interval 807.0 to 8736.0
|
2426.0 U/L
Interval 998.0 to 7420.0
|
1224.5 U/L
Interval 224.0 to 17232.0
|
1987.0 U/L
Interval 452.0 to 3246.0
|
SECONDARY outcome
Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28Population: Baseline is defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose
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.
Outcome measures
| Measure |
Moderate AH DUR-928 30 mg
n=4 Participants
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)
|
Moderate AH DUR-928 90 mg
n=3 Participants
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)
|
Severe AH DUR-928 30 mg
n=4 Participants
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
|
Severe AH DUR-928 90 mg
n=4 Participants
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
|
Severe AH DUR-928 150 mg
n=4 Participants
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
|
|---|---|---|---|---|---|
|
International Normalized Ratio (INR) - Percent Change From Baseline
Day 7 Percent Change from Baseline
|
-10.000 Percent Change
Interval -11.11 to 7.35
|
-3.226 Percent Change
Interval -8.33 to 7.14
|
4.768 Percent Change
Interval -8.88 to 10.53
|
0.000 Percent Change
Interval -5.26 to 43.75
|
0.000 Percent Change
Interval -8.33 to 6.67
|
|
International Normalized Ratio (INR) - Percent Change From Baseline
Day 28 Percent Change from Baseline
|
-3.676 Percent Change
Interval -22.22 to 0.0
|
0.000 Percent Change
Interval 0.0 to 0.0
|
-19.402 Percent Change
Interval -29.68 to 17.65
|
-3.180 Percent Change
Interval -21.05 to 18.75
|
0.000 Percent Change
Interval -33.33 to 42.11
|
SECONDARY outcome
Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28Population: Baseline is defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose
ITT population
Outcome measures
| Measure |
Moderate AH DUR-928 30 mg
n=4 Participants
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)
|
Moderate AH DUR-928 90 mg
n=3 Participants
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)
|
Severe AH DUR-928 30 mg
n=4 Participants
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
|
Severe AH DUR-928 90 mg
n=4 Participants
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
|
Severe AH DUR-928 150 mg
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Bilirubin - Percent Change From Baseline
Day 7 Percent Change from Baseline
|
-15.69 Percent Change
Interval -34.5 to 17.1
|
-31.03 Percent Change
Interval -43.9 to -29.3
|
-25.19 Percent Change
Interval -49.8 to -9.0
|
-6.48 Percent Change
Interval -25.1 to 6.6
|
4.96 Percent Change
Interval -29.3 to 24.7
|
|
Bilirubin - Percent Change From Baseline
Day 28 Percent Change from Baseline
|
-27.27 Percent Change
Interval -40.0 to -5.9
|
-74.27 Percent Change
Interval -75.6 to -72.9
|
-56.93 Percent Change
Interval -74.1 to 34.0
|
-34.82 Percent Change
Interval -47.9 to 50.0
|
-10.04 Percent Change
Interval -63.6 to 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Screening or Day 1 Pre-dose)Population: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.
Serum Creatinine (sCR) at baseline is provided as part of the calculation for MELD
Outcome measures
| Measure |
Moderate AH DUR-928 30 mg
n=4 Participants
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)
|
Moderate AH DUR-928 90 mg
n=3 Participants
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)
|
Severe AH DUR-928 30 mg
n=4 Participants
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
|
Severe AH DUR-928 90 mg
n=4 Participants
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
|
Severe AH DUR-928 150 mg
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Serum Creatinine (sCR)
Baseline (Screening)
|
0.620 mg/dL
Interval 0.46 to 0.8
|
0.710 mg/dL
Interval 0.2 to 0.84
|
0.795 mg/dL
Interval 0.63 to 1.2
|
0.765 mg/dL
Interval 0.59 to 1.5
|
0.610 mg/dL
Interval 0.5 to 1.0
|
|
Serum Creatinine (sCR)
Baseline (Day 1-Pre dose)
|
—
|
0.660 mg/dL
Interval 0.66 to 0.66
|
0.640 mg/dL
Interval 0.61 to 0.78
|
0.580 mg/dL
Interval 0.58 to 0.58
|
0.520 mg/dL
Interval 0.5 to 0.7
|
Adverse Events
Moderate AH DUR-928 30 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Moderate AH DUR-928 90 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Severe AH DUR-928 30 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Severe AH DUR-928 90 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Severe AH DUR-928 150 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Moderate AH DUR-928 30 mg
n=4 participants at risk
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)
|
Moderate AH DUR-928 90 mg
n=3 participants at risk
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)
|
Severe AH DUR-928 30 mg
n=4 participants at risk
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
|
Severe AH DUR-928 90 mg
n=4 participants at risk
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
|
Severe AH DUR-928 150 mg
n=4 participants at risk
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
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
Other adverse events
| Measure |
Moderate AH DUR-928 30 mg
n=4 participants at risk
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)
|
Moderate AH DUR-928 90 mg
n=3 participants at risk
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)
|
Severe AH DUR-928 30 mg
n=4 participants at risk
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
|
Severe AH DUR-928 90 mg
n=4 participants at risk
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
|
Severe AH DUR-928 150 mg
n=4 participants at risk
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
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
50.0%
2/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
50.0%
2/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
33.3%
1/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Investigations
Weight increased
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Renal and urinary disorders
Renal pain
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
25.0%
1/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
33.3%
1/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
33.3%
1/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
33.3%
1/3 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
0.00%
0/4 • 28 days
If subject was not available in person, they were contacted via phone.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER