Trial Outcomes & Findings for A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC) (NCT NCT03394781)
NCT ID: NCT03394781
Last Updated: 2022-10-17
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Day 28 (end of treatment) and Day 56 (end of study/early termination)
Results posted on
2022-10-17
Participant Flow
Study was terminated early due to lack of enrollment.
Participant milestones
| Measure |
DUR-928 10 mg
10 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
DUR-928 50 mg
50 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
Baseline characteristics by cohort
| Measure |
DUR-928 10 mg
n=3 Participants
10 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
DUR-928 50 mg
n=2 Participants
50 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 (end of treatment) and Day 56 (end of study/early termination)Outcome measures
| Measure |
DUR-928 10 mg
n=3 Participants
10 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
DUR-928 50 mg
n=2 Participants
50 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
|---|---|---|
|
Percent Change of Alkaline Phosphatase (ALP) From Baseline
Percent change of ALP from baseline to Day 28
|
23.7 percent change
Standard Deviation 10.7
|
16.8 percent change
Standard Deviation 2.97
|
|
Percent Change of Alkaline Phosphatase (ALP) From Baseline
Percent change of ALP from baseline to Day 56
|
10.7 percent change
Standard Deviation 17.04
|
11.05 percent change
Standard Deviation 8.68
|
SECONDARY outcome
Timeframe: Day 28 and Day 56Population: Study terminated early due to lack of enrollment.
Liver enzymes include alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), bilirubin. Percent change from baseline through the end of study treatment (Day 28) and throughout the follow-up period (Day 56).
Outcome measures
| Measure |
DUR-928 10 mg
n=3 Participants
10 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
DUR-928 50 mg
n=2 Participants
50 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
|---|---|---|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent ALT change from baseline to Day 28
|
32.87 percent change
Standard Deviation 48.87
|
3.0 percent change
Standard Deviation 29.56
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent AST change from baseline to Day 28
|
24.10 percent change
Standard Deviation 35.03
|
-20.25 percent change
Standard Deviation 3.23
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent GGT change from baseline to Day 28
|
7.3 percent change
Standard Deviation 4.16
|
8.15 percent change
Standard Deviation 1.49
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent direct bilirubin change from baseline to Day 28
|
14.2 percent change
Standard Deviation 24.61
|
34.6 percent change
Standard Deviation NA
Standard Deviation not calculable because data were only collected for 1 participant.
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent total bilirubin change from baseline to Day 28
|
12.03 percent change
Standard Deviation 23.09
|
23.85 percent change
Standard Deviation 33.73
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent serum bile acids change from baseline to Day 28
|
-13.93 percent change
Standard Deviation 15.00
|
-44.10 percent change
Standard Deviation 46.95
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent ALT change from baseline to Day 56
|
-9.77 percent change
Standard Deviation 15.30
|
-12.7 percent change
Standard Deviation 5.66
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent AST change from baseline to Day 56
|
-16.23 percent change
Standard Deviation 9.17
|
-9.70 percent change
Standard Deviation 19.09
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent GGT change from baseline to Day 56
|
-7.10 percent change
Standard Deviation 11.87
|
-3.2 percent change
Standard Deviation 2.26
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent direct bilirubin change from baseline to Day 56
|
-12.90 percent change
Standard Deviation NA
Standard Deviation not calculable because data were only collected for 1 participant.
|
19.20 percent change
Standard Deviation NA
Standard Deviation not calculable because data were only collected for 1 participant.
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent total bilirubin change from baseline to Day 56
|
-24.60 percent change
Standard Deviation 20.46
|
19.14 percent change
Standard Deviation 15.61
|
|
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
percent serum bile acids change from baseline to Day 56
|
35.23 percent change
Standard Deviation 79.79
|
-35.75 percent change
Standard Deviation 72.90
|
SECONDARY outcome
Timeframe: Day 28 (end of treatment) and Day 56 (end of follow-up)Outcome measures
| Measure |
DUR-928 10 mg
n=3 Participants
10 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
DUR-928 50 mg
n=2 Participants
50 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
|---|---|---|
|
Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline
subjects with ≥ 40% reduction of serum ALP from baseline at day 28/end of treatment
|
0 Participants
|
0 Participants
|
|
Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline
subjects with ≥ 40% reduction of serum ALP from baseline at day 56/end of follow-up
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 and Day 56Population: The samples were not assayed to generate data for this Outcome Measure due to early study termination.
Outcome measures
Outcome data not reported
Adverse Events
DUR-928 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DUR-928 50 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DUR-928 10 mg
n=3 participants at risk
10 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
DUR-928 50 mg
n=2 participants at risk
50 mg oral suspension
DUR-928: oral suspension daily for 28 days
|
|---|---|---|
|
Hepatobiliary disorders
DRUG INDUCED LIVER INJURY
|
33.3%
1/3 • Number of events 1 • 56 days
Treatment Emergent Adverse Events
|
0.00%
0/2 • 56 days
Treatment Emergent Adverse Events
|
|
Cardiac disorders
WORSENING SINUS BRADYCARDIA
|
33.3%
1/3 • Number of events 1 • 56 days
Treatment Emergent Adverse Events
|
0.00%
0/2 • 56 days
Treatment Emergent Adverse Events
|
|
Gastrointestinal disorders
EXCESSIVE GAS (FLATUS)
|
33.3%
1/3 • Number of events 1 • 56 days
Treatment Emergent Adverse Events
|
0.00%
0/2 • 56 days
Treatment Emergent Adverse Events
|
|
Investigations
ELEVATED ALKALINE PHOSPHATASE
|
0.00%
0/3 • 56 days
Treatment Emergent Adverse Events
|
50.0%
1/2 • Number of events 1 • 56 days
Treatment Emergent Adverse Events
|
|
Investigations
ELEVATED ALT
|
0.00%
0/3 • 56 days
Treatment Emergent Adverse Events
|
50.0%
1/2 • Number of events 1 • 56 days
Treatment Emergent Adverse Events
|
|
Investigations
ELEVATED AST
|
0.00%
0/3 • 56 days
Treatment Emergent Adverse Events
|
50.0%
1/2 • Number of events 1 • 56 days
Treatment Emergent Adverse Events
|
|
Investigations
ELEVATED GGT
|
0.00%
0/3 • 56 days
Treatment Emergent Adverse Events
|
50.0%
1/2 • Number of events 1 • 56 days
Treatment Emergent Adverse Events
|
|
Investigations
ELEVATED SERUM BILE ACIDS
|
0.00%
0/3 • 56 days
Treatment Emergent Adverse Events
|
50.0%
1/2 • Number of events 1 • 56 days
Treatment Emergent Adverse Events
|
|
Skin and subcutaneous tissue disorders
LEFT EAR ERYTHEMA PRESENT
|
0.00%
0/3 • 56 days
Treatment Emergent Adverse Events
|
50.0%
1/2 • Number of events 1 • 56 days
Treatment Emergent Adverse Events
|
Additional Information
Executive Director, Regulatory Affairs
DURECT Corporation
Phone: 408-777-1829
Email: [email protected]
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 105-120 days after submission to sponsor.
- Publication restrictions are in place
Restriction type: OTHER