Detoxification of the Liver In PSC (Dolphin)
Recruiting
Phase 2
Interventional Study
Primary Sclerosing Cholangitis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 28 (estimated)
- Sponsor
- Brigham and Women's Hospital · Other
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About This Trial
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 o…
Trial Locations
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Eligibility Criteria
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 ei…
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