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New treatment option for Primary Sclerosing Cholangitis
Official title Detoxification of the Liver In PSC (Dolphin)
ClinicalTrials.gov ID: NCT05835505
What this study is testing
What is BRS201?
BRS201 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for primary sclerosing cholangitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- A diagnosis of PSC for at least 6 months based upon cholangiography (ERCP or MRCP) demonstrating intrahepatic and/or extrahepatic biliary strictures...
- 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...
You likely can't join 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 \ 1.4
- Concomitant chronic liver disease including alcohol related liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson's disease...
- Secondary causes of sclerosing cholangitis
- Patients who have a confirmed malignancy or cancer within 5 years except non-melanoma skin cancers
See the full eligibility 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%...
- 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 \ 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chestnut Hill, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chestnut Hill, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.