Actively Recruiting
Detoxification of the Liver In PSC (Dolphin)
Led by Brigham and Women's Hospital · Updated on 2025-11-06
28
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a clinical trial being done to investigate the efficacy of drug BRS201 (hydroxocobalamin) as a treatment in patients with primary sclerosing cholangitis. Participation in this study will take 8 weeks long and the study is structured as a cross-over study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 9 study visits, all of which will be remote. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool sample for a few lab tests throughout the study. For the lab tests, a research nurse will visit the participant in-home for the convenience of the participant.
CONDITIONS
Official Title
Detoxification of the Liver In PSC (Dolphin)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary sclerosing cholangitis for at least 6 months based on cholangiography showing characteristic biliary changes
- Alkaline phosphatase level greater than 1.5 times the upper limit of normal at screening
- On a stable dose of ursodeoxycholic acid for more than 6 months prior to screening or discontinued more than 4 weeks before screening (with enrollment capped at 60% for patients on this treatment)
You will not qualify if you...
- Anticipated need for liver transplant within one year as assessed by Mayo PSC risk score
- Signs of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy
- Advanced liver disease indicated by MELD score above 10, bilirubin over 3.0, low platelet count below 100,000, or INR above 1.4
- Other chronic liver diseases including alcohol-related liver disease, chronic hepatitis B or C, haemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliary cholangitis
- Secondary causes of sclerosing cholangitis
- History of malignancy or cancer within the last 5 years except non-melanoma skin cancers
- Use of investigational drugs within two months or 5 half-lives, whichever is longer
- Active illicit drug use or more than moderate alcohol consumption
- Bacterial cholangitis within 6 months prior to enrollment
- Need for additional therapy for ulcerative colitis or Crohn's disease at screening
- Chronic kidney injury with eGFR below 60
- Pregnancy or breastfeeding
- Uncontrolled high blood pressure with systolic over 140 or diastolic over 90
- Current use of vitamin C or prednisone
- History or risk of cardiovascular conditions such as arrhythmia, long QT syndrome, heart failure, stroke, or coronary artery disease
- History of kidney stones
- Congenital or acquired immunodeficiencies
- Other comorbidities including diabetes mellitus or systemic lupus
- Acute cholangitis episode within 4 weeks of screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Actively Recruiting
Research Team
S
Sophie Mitchell, BS
CONTACT
S
Siani Ellis, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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