Treatment for liver detoxification in patients with primary sclerosing cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of BRS201 (hydroxocobalamin) in treating patients with primary sclerosing cholangitis (PSC). The study is designed as a cross-over trial where participants will receive the study drug for 4 weeks followed by a placebo for another 4 weeks, with randomization in the order of administration. Participants will take the medication orally twice daily and will have 9 remote study visits, including in-home lab tests conducted by a research nurse. The trial aims to assess the drug's impact on liver function and overall health in PSC patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Brigham and Women's Hospital
  Chestnut Hill, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Joshua A Korzenik, MD — Brigham and Womens Hospital
• Study coordinator: Sophie Mitchell, BS
• Email: smitchell22@bwh.harvard.edu
• Phone: 5089363674

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.