- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05835505
Detoxification of the Liver In PSC (Dolphin) (DOLPHIN)
Detoxification of the Liver in Primary Sclerosing Cholangitis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Joshua Korzenik, MD
- Phone Number: 617 732-6389
- Email: jkorzenik@bwh.harvard.edu
Study Contact Backup
- Name: CHaru Madhwani
- Phone Number: 617 732-9119
Study Locations
-
-
Massachusetts
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Chestnut Hill, Massachusetts, United States, 02467
- Recruiting
- Brigham and Women's Hospital
-
Principal Investigator:
- Joshua Korzenik, MD
-
Contact:
- Marin Waddington
- Phone Number: 617-732-9451
- Email: mwaddington@bwh.harvard.edu
-
Contact:
- Sophie Mitchell
- Email: smitchell22@bwh.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A diagnosis of PSC for at least 6 months based upon cholangiography (ERCP or MRCP) demonstrating intrahepatic and/or extrahepatic biliary strictures, beading or irregularity consistent with PSC.
- ALP > 1.5 times the upper limit of normal (ULN) at screening.
- Subject must either be on a stable dose of ursodeoxycholic acid for > 6 months prior to screening or have been discontinued > 4 weeks prior to screening (enrollment of patients who are on UDCA will be limited to 60% of all enrolled patients).
Exclusion Criteria:
- Anticipated need for liver transplant within one year as determined by Mayo PSC risk score
- Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy.
- Evidence of advanced liver disease including MELD score > 10, bilirubin > 3.0, platelet count < 100,000; or INR > 1.4
- Concomitant chronic liver disease including alcohol related liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliary cholangitis
- Secondary causes of sclerosing cholangitis
- Patients who have a confirmed malignancy or cancer within 5 years except non-melanoma skin cancers
- Treatment with any investigational agents, within two months or 5 half-lives of the investigational product, whichever is longer.
- Active illicit drug or more than moderate alcohol consumption.
- Evidence of bacterial cholangitis within 6 months of enrollment
- In patients with Ulcerative Colitis, or, if Crohn's disease, a need for additional therapy at time of screening.
- Chronic kidney injury (eGFR < 60)
- Pregnancy or lactation
- Uncontrolled hypertension with a systolic BP > 140 and a systolic BP > 90
- Prohibited medications: current use of vitamin C and prednisone
- Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
- Patients with a history of kidney stones
- Congenital or acquired immunodeficiencies
- Other comorbidities including: diabetes mellitus, systemic lupus
- An episode of acute cholangitis within 4 weeks of screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: BRS201 Arm
In Group 1 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) for 4 weeks. In Group 2 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) for 4 weeks. In Group 3 of the study, subjects will take receive a one-time 5g IV dose of the study drug using the FDA-approved IV product followed by the oral study drug at 2g twice daily, PO (4g daily) for 4 weeks. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective. |
Groups 1, 2, 3, and 4 will all contain 7 subjects each, with each subject receiving active study drug and placebo in a randomized order; half will receive the placebo first for four weeks followed by active treatment for four weeks, while the other half will receive active treatment for four weeks followed by placebo for four weeks.
|
Placebo Comparator: Placebo Arm
In Group 1 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) for 4 weeks. In Group 2 of the study, subjects will take oral placebo at 2g twice daily, PO (4g daily) for 4 weeks. In Group 3 of the study, subjects will take receive a one-time 5g IV dose of the study drug using the FDA-approved IV product followed by the oral placebo at 2g twice daily, PO (4g daily) for 4 weeks. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective. |
Groups 1, 2, 3, and 4 will all contain 7 subjects each, with each subject receiving active study drug and placebo in a randomized order; half will receive the placebo first for four weeks followed by active treatment for four weeks, while the other half will receive active treatment for four weeks followed by placebo for four weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alkaline Phosphatase (ALP) Test Result
Time Frame: 4 weeks
|
The primary endpoint for this study is the capacity of BRS201 to normalize alkaline phosphatase levels from baseline (week 0) compared to end of active treatment (4 weeks).
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023P000535
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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