Detoxification of the Liver In PSC (Dolphin)

Last updated: April 28, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Disorders

Primary Biliary Cholangitis

Gall Bladder Disorders

Treatment

Placebo

BRS201

Clinical Study ID

NCT05835505
2025P000196
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 orirregularity 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 priorto screening or have been discontinued > 4 weeks prior to screening (enrollment ofpatients who are on UDCA will be limited to 60% of all enrolled patients).

Exclusion

Exclusion Criteria:

  • Anticipated need for liver transplant within one year as determined by Mayo PSC riskscore

  • Evidence of decompensated liver disease such as variceal bleeding, ascites, orhepatic 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, chronichepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsindeficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliarycholangitis

  • Secondary causes of sclerosing cholangitis

  • Patients who have a confirmed malignancy or cancer within 5 years exceptnon-melanoma skin cancers

  • Treatment with any investigational agents, within two months or 5 half-lives of theinvestigational 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 additionaltherapy 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

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 12, 2023
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Brigham and Women's Hospital

    Chestnut Hill, Massachusetts 02467
    United States

    Active - Recruiting

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