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A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394781
Recruitment Status : Terminated (poor enrollment)
First Posted : January 9, 2018
Results First Posted : October 17, 2022
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Durect

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Sclerosing Cholangitis
Intervention Drug: DUR-928
Enrollment 5
Recruitment Details Study was terminated early due to lack of enrollment.
Pre-assignment Details  
Arm/Group Title DUR-928 10 mg DUR-928 50 mg
Hide Arm/Group Description

10 mg oral suspension

DUR-928: oral suspension daily for 28 days

50 mg oral suspension

DUR-928: oral suspension daily for 28 days

Period Title: Overall Study
Started 3 2
Completed 3 2
Not Completed 0 0
Arm/Group Title DUR-928 10 mg DUR-928 50 mg Total
Hide Arm/Group Description

10 mg oral suspension

DUR-928: oral suspension daily for 28 days

50 mg oral suspension

DUR-928: oral suspension daily for 28 days

Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
1
  50.0%
4
  80.0%
>=65 years
0
   0.0%
1
  50.0%
1
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
1
  33.3%
1
  50.0%
2
  40.0%
Male
2
  66.7%
1
  50.0%
3
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
2
 100.0%
5
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
1
  50.0%
4
  80.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  50.0%
1
  20.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 2 participants 5 participants
3
 100.0%
2
 100.0%
5
 100.0%
1.Primary Outcome
Title Percent Change of Alkaline Phosphatase (ALP) From Baseline
Hide Description [Not Specified]
Time Frame Day 28 (end of treatment) and Day 56 (end of study/early termination)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DUR-928 10 mg DUR-928 50 mg
Hide Arm/Group Description:

10 mg oral suspension

DUR-928: oral suspension daily for 28 days

50 mg oral suspension

DUR-928: oral suspension daily for 28 days

Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: percent change
Percent change of ALP from baseline to Day 28 23.7  (10.7) 16.8  (2.97)
Percent change of ALP from baseline to Day 56 10.7  (17.04) 11.05  (8.68)
2.Secondary Outcome
Title Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
Hide Description

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).

Time Frame Day 28 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to lack of enrollment.
Arm/Group Title DUR-928 10 mg DUR-928 50 mg
Hide Arm/Group Description:

10 mg oral suspension

DUR-928: oral suspension daily for 28 days

50 mg oral suspension

DUR-928: oral suspension daily for 28 days

Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: percent change
percent ALT change from baseline to Day 28 Number Analyzed 3 participants 2 participants
32.87  (48.87) 3.0  (29.56)
percent AST change from baseline to Day 28 Number Analyzed 3 participants 2 participants
24.10  (35.03) -20.25  (3.23)
percent GGT change from baseline to Day 28 Number Analyzed 3 participants 2 participants
7.3  (4.16) 8.15  (1.49)
percent direct bilirubin change from baseline to Day 28 Number Analyzed 2 participants 1 participants
14.2  (24.61) 34.6 [1]   (NA)
percent total bilirubin change from baseline to Day 28 Number Analyzed 3 participants 2 participants
12.03  (23.09) 23.85  (33.73)
percent serum bile acids change from baseline to Day 28 Number Analyzed 3 participants 2 participants
-13.93  (15.00) -44.10  (46.95)
percent ALT change from baseline to Day 56 Number Analyzed 3 participants 2 participants
-9.77  (15.30) -12.7  (5.66)
percent AST change from baseline to Day 56 Number Analyzed 3 participants 2 participants
-16.23  (9.17) -9.70  (19.09)
percent GGT change from baseline to Day 56 Number Analyzed 3 participants 2 participants
-7.10  (11.87) -3.2  (2.26)
percent direct bilirubin change from baseline to Day 56 Number Analyzed 1 participants 1 participants
-12.90 [1]   (NA) 19.20 [1]   (NA)
percent total bilirubin change from baseline to Day 56 Number Analyzed 3 participants 2 participants
-24.60  (20.46) 19.14  (15.61)
percent serum bile acids change from baseline to Day 56 Number Analyzed 3 participants 2 participants
35.23  (79.79) -35.75  (72.90)
[1]
Standard Deviation not calculable because data were only collected for 1 participant.
3.Secondary Outcome
Title Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline
Hide Description [Not Specified]
Time Frame Day 28 (end of treatment) and Day 56 (end of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DUR-928 10 mg DUR-928 50 mg
Hide Arm/Group Description:

10 mg oral suspension

DUR-928: oral suspension daily for 28 days

50 mg oral suspension

DUR-928: oral suspension daily for 28 days

Overall Number of Participants Analyzed 3 2
Measure Type: Count of Participants
Unit of Measure: Participants
subjects with ≥ 40% reduction of serum ALP from baseline at day 28/end of treatment
0
   0.0%
0
   0.0%
subjects with ≥ 40% reduction of serum ALP from baseline at day 56/end of follow-up
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period.
Hide Description [Not Specified]
Time Frame Day 28 and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The samples were not assayed to generate data for this Outcome Measure due to early study termination.
Arm/Group Title DUR-928 10 mg DUR-928 50 mg
Hide Arm/Group Description:

10 mg oral suspension

DUR-928: oral suspension daily for 28 days

50 mg oral suspension

DUR-928: oral suspension daily for 28 days

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 56 days
Adverse Event Reporting Description Treatment Emergent Adverse Events
 
Arm/Group Title DUR-928 10 mg DUR-928 50 mg
Hide Arm/Group Description

10 mg oral suspension

DUR-928: oral suspension daily for 28 days

50 mg oral suspension

DUR-928: oral suspension daily for 28 days

All-Cause Mortality
DUR-928 10 mg DUR-928 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
DUR-928 10 mg DUR-928 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/2 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DUR-928 10 mg DUR-928 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      1/2 (50.00%)    
Cardiac disorders     
WORSENING SINUS BRADYCARDIA *  1/3 (33.33%)  1 0/2 (0.00%)  0
Gastrointestinal disorders     
EXCESSIVE GAS (FLATUS) *  1/3 (33.33%)  1 0/2 (0.00%)  0
Hepatobiliary disorders     
DRUG INDUCED LIVER INJURY *  1/3 (33.33%)  1 0/2 (0.00%)  0
Investigations     
ELEVATED ALKALINE PHOSPHATASE *  0/3 (0.00%)  0 1/2 (50.00%)  1
ELEVATED ALT *  0/3 (0.00%)  0 1/2 (50.00%)  1
ELEVATED AST *  0/3 (0.00%)  0 1/2 (50.00%)  1
ELEVATED GGT *  0/3 (0.00%)  0 1/2 (50.00%)  1
ELEVATED SERUM BILE ACIDS *  0/3 (0.00%)  0 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders     
LEFT EAR ERYTHEMA PRESENT *  0/3 (0.00%)  0 1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Director, Regulatory Affairs
Organization: DURECT Corporation
Phone: 408-777-1829
EMail: jill.burns@durect.com
Layout table for additonal information
Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT03394781    
Other Study ID Numbers: C928-008
First Submitted: January 3, 2018
First Posted: January 9, 2018
Results First Submitted: August 10, 2022
Results First Posted: October 17, 2022
Last Update Posted: October 17, 2022