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Could a form of vitamin B12 help control a rare liver disease?

NCT ID NCT05835505

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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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Conditions

The condition(s) this trial relates to.

Cholangitis, Sclerosing primary sclerosing cholangitis

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Chestnut Hill, Massachusetts, 02467, United States

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