Could a form of vitamin B12 help control a rare liver disease?
NCT ID NCT05835505
First seen Jun 25, 2026 · Last updated Jul 22, 2026 · Updated 3 times
Summary
This Phase 2 trial tests whether the drug BRS201 (a form of vitamin B12) can improve liver health in people with primary sclerosing cholangitis (PSC), a rare liver disease. Over 8 weeks, 28 participants will take either the drug or a placebo for 4 weeks each, in random order. The main goal is to see if BRS201 lowers a key liver enzyme called alkaline phosphatase, which is often high in PSC.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BRS201 (hydroxocobalamin, a form of vitamin B12)
- What this could lead to
- If it works, this could point toward a treatment to control liver damage in primary sclerosing cholangitis by lowering key liver enzyme levels.
- What could go wrong
- This is a small, early Phase 2 trial with only 28 people. It tests a short-term effect on a lab marker, not long-term outcomes, so results may not lead to a proven treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Check eligibility here: https://redcap.link/Checkmyeligibility
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Primary sclerosing cholangitis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Brigham and Women's Hospital
RECRUITINGChestnut Hill, Massachusetts, 02467, United States
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