Detoxification of the Liver In PSC (Dolphin)
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Brigham and Women's Hospital
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.
Where it's recruiting
Chestnut Hill
Source: ClinicalTrials.gov · NCT05835505 · last updated 2025-11-06