PSCRecruiting
Detoxification of the Liver In PSC (Dolphin)
Phase 2 · Testing BRS201 · 1 site · Brigham and Women's Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing BRS201 (a drug) as a possible treatment. Condition(s) listed: Primary Sclerosing Cholangitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 19 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 28 participants are expected to take part.
- The study has 2 groups.
- Start date: 2023-12-12.
- Main results expected around 2027-05-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- BRS201 Arm (listed as: active comparator group)
- Placebo Arm (listed as: placebo group)
Main thing being measured
- Alkaline Phosphatase (ALP) Test Result (4 weeks)
In the researchers’ words
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.…
Words you might see
- ALP (alkaline phosphatase): a liver blood test that is often high in PSC.
- ULN: upper limit of normal: the top of the usual range for a lab test.
- MRCP: an MRI scan of the bile ducts and pancreas.
- ERCP: a procedure using a scope and dye to look at (and sometimes treat) the bile ducts.
- UDCA (ursodiol): a bile acid medicine that some people with PSC take.
- Bilirubin: a yellow substance measured in blood; high levels can be a sign of liver or bile-duct problems.
- MELD score: a score based on lab tests used to estimate how severe liver disease is.
- Decompensated liver disease: advanced liver disease with complications such as fluid build-up or bleeding.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Primary Sclerosing Cholangitis |
| Lead sponsor | Brigham and Women's Hospital |
| Enrollment | 28 (estimated) |
| Start date | 2023-12-12 |
| Primary completion (est.) | 2027-05-01 |
| First posted | 2023-04-28 |
| Last updated | 2026-07-21 |
| Official title | Detoxification of the Liver in Primary Sclerosing Cholangitis |
| ClinicalTrials.gov ID | NCT05835505 |
Interventions
- BRS201 (Drug)
Groups 1, 2, 3, and 4 will all contain 7 subjects each, with each subject receiving active study drug and placebo in a randomized order; half will receive the placebo first for four weeks followed by active treatment for four weeks, while the other half will receive active treatment for four weeks followed by placebo for four weeks. - Placebo (Drug)
Groups 1, 2, 3, and 4 will all contain 7 subjects each, with each subject receiving active study drug and placebo in a randomized order; half will receive the placebo first for four weeks followed by active treatment for four weeks, while the other half will receive active treatment for four weeks followed by placebo for four weeks.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital | Chestnut Hill, Massachusetts | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.