NCT03394781

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 17, 2022

Completed
Last Updated

October 17, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

January 3, 2018

Results QC Date

August 10, 2022

Last Update Submit

September 20, 2022

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

  • Percent Change of Alkaline Phosphatase (ALP) From Baseline

    Day 28 (end of treatment) and Day 56 (end of study/early termination)

Secondary Outcomes (3)

  • Percent Change of Liver Enzymes and Serum Bile Acids (sBA)

    Day 28 and Day 56

  • Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline

    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.

    Day 28 and Day 56

Study Arms (2)

DUR-928 10 mg

EXPERIMENTAL

10 mg oral suspension

Drug: DUR-928

DUR-928 50 mg

EXPERIMENTAL

50 mg oral suspension

Drug: DUR-928

Interventions

DUR-928DRUG

oral suspension daily for 28 days

DUR-928 10 mgDUR-928 50 mg

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Verified diagnosis of primary sclerosing cholangitis (PSC) for at least 12 months, with or without inflammatory bowel disease (IBD).
  • Serum alkaline phosphatase (ALP) ≥ 1.5 times ULN and with no \>15% fluctuation in the past 3 months.
  • In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.
  • Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.

You may not qualify if:

  • Presence of documented secondary sclerosing cholangitis or small duct PSC
  • Bacterial cholangitis within 30 days prior to Screening
  • Presence of percutaneous drain or endoscopic bile duct stent
  • History of, or suspicion of cholangiocarcinoma.
  • Prior liver transplantation, or currently listed for liver transplantation
  • Presence of other concomitant liver diseases
  • Moderate to Severe active IBD or flare in colitis activity within the last 3 months
  • Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder
  • Any active malignant disease (within 3 years), other than non-melanomatous skin cancer
  • Human immunodeficiency virus (HIV) infection
  • Existing or intended pregnancy, or breast feeding
  • Has received medication from another clinical trial within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Southern Therapy and Advanced Research

Jackson, Mississippi, 39216, United States

Location

Charlotte Mecklenburg Hospital

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Results Point of Contact

Title
Executive Director, Regulatory Affairs
Organization
DURECT Corporation
jill.burns@durect.com
408-777-1829

Study Officials

  • Alastair Smith, MD

    INC Research/InVentiv Health

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 9, 2018

Study Start

January 22, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

October 17, 2022

Results First Posted

October 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(4)