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BRS201 for Primary Sclerosing Cholangitis (Dolphin Study)

This study is testing if BRS201 (hydroxocobalamin) can help people with Primary Sclerosing Cholangitis (PSC), a liver condition. You might be able to join if you are 18-75 years old, have had PSC for at least 6 months, and your Alkaline Phosphatase (ALP) levels are high. The study aims to see if BRS201 can lower ALP levels after 4 weeks. This study is currently recruiting about 28 participants, but its overall status is unclear.

Study design
This is an interventional study where 28 participants will receive BRS201 and a placebo in a randomized, crossover order. Each participant will take BRS201 for four weeks and a placebo for four weeks.
What's involved
You would participate for 8 weeks, attending 9 remote visits. You'll take an oral medication twice daily, track it in a log, and provide blood and stool samples for lab tests. You might also receive an IV dose of the medication.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Alkaline Phosphatase (ALP) Test Result, is measured at 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05835505

Detoxification of the Liver In PSC (Dolphin)

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Brigham and Women's Hospital
~28 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:BRS201Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Alkaline Phosphatase (ALP) Test Result
Measured over 4 weeks

Conditions

Primary Sclerosing Cholangitis

Explore related trials

Primary Sclerosing Cholangitis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Joshua A Korzenik, MD · PRINCIPAL_INVESTIGATOR · Brigham and Womens Hospital

Who to contact

Sophie Mitchell, BS
[email protected]
5089363674
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 Check eligibility here: https://redcap.link/Checkmyeligibility

What this trial measures

  • Alkaline Phosphatase (ALP) Test Result4 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).