A Phase 2 interventional study of DUR-928 in Primary Sclerosing Cholangitis, sponsored by Durect. Terminated at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-17.
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 the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).
149 studies on the registry are indexed under Cholangitis, Sclerosing; 39 are open to participants now.
This study's enrollment of 5 is below the median of 34 across 94 interventional studies indexed under Cholangitis, Sclerosing.
Browse Cholangitis, Sclerosing 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.
Exclusion Criteria:
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
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.
10 mg oral suspension
Drug: DUR-928
50 mg oral suspension
Drug: DUR-928
oral suspension daily for 28 days
Percent Change of Alkaline Phosphatase (ALP) From Baseline
Time frame: Day 28 (end of treatment) and Day 56 (end of study/early termination)
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
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
Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline
Time frame: Day 28 (end of treatment) and Day 56 (end of follow-up)
Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period.
Time frame: Day 28 and Day 56
Study was terminated early due to lack of enrollment.
| Milestone | DUR-928 10 mg | DUR-928 50 mg |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
| percent change | DUR-928 10 mg | DUR-928 50 mg |
|---|---|---|
| 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 |
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).
| percent change | DUR-928 10 mg | DUR-928 50 mg |
|---|---|---|
| percent ALT change from baseline to Day 28 | 32.87 ± 48.87 | 3.0 ± 29.56 |
| percent AST change from baseline to Day 28 | 24.10 ± 35.03 | -20.25 ± 3.23 |
| percent GGT change from baseline to Day 28 | 7.3 ± 4.16 | 8.15 ± 1.49 |
| percent direct bilirubin change from baseline to Day 28 | 14.2 ± 24.61 | 34.6 ± NA |
| percent total bilirubin change from baseline to Day 28 | 12.03 ± 23.09 | 23.85 ± 33.73 |
| percent serum bile acids change from baseline to Day 28 | -13.93 ± 15.00 | -44.10 ± 46.95 |
| percent ALT change from baseline to Day 56 | -9.77 ± 15.30 | -12.7 ± 5.66 |
| percent AST change from baseline to Day 56 | -16.23 ± 9.17 | -9.70 ± 19.09 |
| percent GGT change from baseline to Day 56 | -7.10 ± 11.87 | -3.2 ± 2.26 |
| percent direct bilirubin change from baseline to Day 56 | -12.90 ± NA | 19.20 ± NA |
| percent total bilirubin change from baseline to Day 56 | -24.60 ± 20.46 | 19.14 ± 15.61 |
| percent serum bile acids change from baseline to Day 56 | 35.23 ± 79.79 | -35.75 ± 72.90 |
| Participants | DUR-928 10 mg | DUR-928 50 mg |
|---|---|---|
| subjects with ≥ 40% reduction of serum ALP from baseline at day 28/end of treatment | 0 | 0 |
| subjects with ≥ 40% reduction of serum ALP from baseline at day 56/end of follow-up | 0 | 0 |
No measurements were reported for this outcome.
Collected over 56 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DUR-928 10 mg | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| DUR-928 50 mg | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Event | DUR-928 10 mg | DUR-928 50 mg |
|---|---|---|
| ELEVATED ALKALINE PHOSPHATASEInvestigations | 0/3 | 1/2 |
| ELEVATED ALTInvestigations | 0/3 | 1/2 |
| ELEVATED ASTInvestigations | 0/3 | 1/2 |
| ELEVATED GGTInvestigations | 0/3 | 1/2 |
| ELEVATED SERUM BILE ACIDSInvestigations | 0/3 | 1/2 |
| LEFT EAR ERYTHEMA PRESENTSkin and subcutaneous tissue disorders | 0/3 | 1/2 |
| DRUG INDUCED LIVER INJURYHepatobiliary disorders | 1/3 | 0/2 |
| WORSENING SINUS BRADYCARDIACardiac disorders | 1/3 | 0/2 |
| EXCESSIVE GAS (FLATUS)Gastrointestinal disorders | 1/3 | 0/2 |
| Age, Categorical(Participants) | DUR-928 10 mg | DUR-928 50 mg | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 1 | 4 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | DUR-928 10 mg | DUR-928 50 mg | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | DUR-928 10 mg | DUR-928 50 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DUR-928 10 mg | DUR-928 50 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 1 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | DUR-928 10 mg | DUR-928 50 mg | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Larsucosterol