RECRUITING

Detoxification of the Liver In PSC (Dolphin)

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Conditions

Primary Sclerosing Cholangitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Detoxification of the Liver in Primary Sclerosing Cholangitis

Quick Facts

Study Start:2023-12-12
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05835505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * ALP \> 1.5 times the upper limit of normal (ULN) at screening.
  3. * 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).
  1. * Anticipated need for liver transplant within one year as determined by Mayo PSC risk score
  2. * Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy.
  3. * Evidence of advanced liver disease including MELD score \> 10, bilirubin \> 3.0, platelet count \< 100,000; or INR \> 1.4
  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
  5. * Secondary causes of sclerosing cholangitis
  6. * Patients who have a confirmed malignancy or cancer within 5 years except non-melanoma skin cancers
  7. * Treatment with any investigational agents, within two months or 5 half-lives of the investigational product, whichever is longer.
  8. * Active illicit drug or more than moderate alcohol consumption.
  9. * Evidence of bacterial cholangitis within 6 months of enrollment
  10. * In patients with Ulcerative Colitis, or, if Crohn's disease, a need for additional therapy at time of screening.
  11. * Chronic kidney injury (eGFR \< 60)
  12. * Pregnancy or lactation
  13. * Uncontrolled hypertension with a systolic BP \> 140 and a systolic BP \> 90
  14. * Prohibited medications: current use of vitamin C and prednisone
  15. * Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
  16. * Patients with a history of kidney stones
  17. * Congenital or acquired immunodeficiencies
  18. * Other comorbidities including: diabetes mellitus, systemic lupus
  19. * An episode of acute cholangitis within 4 weeks of screening

Contacts and Locations

Study Contact

Joshua Korzenik, MD
CONTACT
617 732-6389
jkorzenik@bwh.harvard.edu
Sophie Mitchell, BS
CONTACT
509-936-3674
smitchell22@bwh.harvard.edu

Principal Investigator

Joshua A Korzenik, MD
PRINCIPAL_INVESTIGATOR
Brigham and Womens Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Joshua A Korzenik, MD, PRINCIPAL_INVESTIGATOR, Brigham and Womens Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-12
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-12-12
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Primary Sclerosing Cholangitis