Actively Recruiting
Detoxification of the Liver in Primary Sclerosing Cholangitis
Led by Brigham and Women's Hospital · Updated on 2025-11-06
28
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug BRS201 (hydroxocobalamin) as a treatment for patients with primary sclerosing cholangitis (PSC), a liver condition. This Phase 2 clinical trial is designed as a randomized, quadruple-masked, cross-over study to assess the drug's effects compared to a placebo. The study lasts 8 weeks, with participants taking BRS201 and placebo in a randomized sequence to measure the drug's impact on the liver enzyme alkaline phosphatase (ALP). Participants will be assigned to one of four groups receiving different dosing schedules. Groups 1 and 2 receive oral BRS201 twice daily at doses of 1.2g or 2g, respectively, for 4 weeks, followed by placebo for 4 weeks or vice versa. Group 3 receives a one-time 5g intravenous dose of BRS201, then oral BRS201 twice daily for 4 weeks, alternating with placebo. Group 4 repeats the dosing regimen found most effective in earlier groups. All treatments are oral medications taken twice daily, and the study uses a cross-over design to compare active drug and placebo effects. Participants will have 9 remote study visits over 8 weeks and will track their medication intake in a log. Blood samples and stool specimens will be collected for lab tests, with a research nurse visiting the participant's home for convenience. The primary outcome measured is the change in alkaline phosphatase levels after 4 weeks of treatment. The study monitors participants closely through lab tests and remote visits to assess liver function and safety throughout the trial.
CONDITIONS
Brief Title
Detoxification of the Liver In PSC (Dolphin)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of primary sclerosing cholangitis for at least 6 months confirmed by cholangiography
- Alkaline phosphatase greater than 1.5 times the upper limit of normal at screening
- Stable dose of ursodeoxycholic acid for more than 6 months prior or discontinued more than 4 weeks prior to screening
- Enrollment of patients on ursodeoxycholic acid limited to 60% of all enrolled patients
You will not qualify if you...
- Anticipated need for liver transplant within one year
- Evidence of decompensated liver disease (variceal bleeding, ascites, hepatic encephalopathy)
- Advanced liver disease (MELD score over 10, bilirubin over 3.0, platelet count under 100,000, INR over 1.4)
- Other chronic liver diseases (alcohol-related, hepatitis B or C, haemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency, NASH, autoimmune hepatitis, primary biliary cholangitis)
- Secondary causes of sclerosing cholangitis
- History of malignancy or cancer within 5 years except non-melanoma skin cancers
- Treatment with investigational agents within two months or 5 half-lives
- Active illicit drug use or more than moderate alcohol use
- Bacterial cholangitis within 6 months
- Need for additional therapy if diagnosed with ulcerative colitis or Crohn's disease
- Chronic kidney injury (eGFR less than 60)
- Pregnancy or lactation
- Uncontrolled hypertension (systolic BP over 140 and diastolic BP over 90)
- Current use of vitamin C and prednisone
- History or risk of cardiovascular conditions including arrhythmia, long QT syndrome, congestive heart failure, stroke, coronary artery disease
- History of kidney stones
- Congenital or acquired immunodeficiencies
- Other comorbidities including diabetes mellitus and systemic lupus
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive either the active study drug BRS201 or placebo in a randomized crossover design. Each participant receives both treatments for four weeks each in a randomized order, with some groups receiving an initial one-time IV dose followed by oral dosing.
Visits during each 4-week treatment period as scheduled by the study
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
S
Siani Ellis, BS
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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