Detoxification of the Liver In PSC (Dolphin)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Primary Sclerosing Cholangitis

In brief

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. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 9 study visits, all of which will be remote. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool sample for a few lab tests throughout the study. For the lab tests, a research nurse will visit the participant in-home for the convenience of the participant.

Key facts

Study ID: NCT05835505
Run by: Brigham and Women's Hospital
People needed: 28
Starts: 2023-12-12
Expected to finish: 2027-06-01
Last updated by the study team: 2026-07-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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