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NCT Number: NCT05835505

Detoxification of the Liver In PSC (Dolphin)

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.

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Key information

Conditions

Primary Sclerosing Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Alkaline Phosphatase (ALP) Test Result

    Time frame: 4 weeks

    The primary endpoint for this study is the capacity of BRS201 to normalize alkaline phosphatase levels from baseline (week 0) compared to end of active treatment (4 weeks).

Study contacts

Contact information is provided by the study sponsor or research team.

Siani Ellis, BS

CONTACT

[email protected]

6177325500 ext. 29281

Sophie Mitchell, BS

CONTACT

[email protected]

5089363674

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Detoxification of the Liver in Primary Sclerosing Cholangitis

Acronym: DOLPHIN

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 28, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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