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NCT05835505 · ClinicalTrials.gov registry record · Phase 2
Detoxification of the Liver In PSC (Dolphin)
A Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05835505: Recruiting Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Brigham and Women's Hospital.
NCT05835505 is a Phase 2 study of Primary Sclerosing Cholangitis that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 28 participants, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05835505, a Phase 2 study of Primary Sclerosing Cholangitis, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The primary endpoint for this study is the capacity of BRS201 to normalize alkaline phosphatase levels from baseline (week 0) compared to end of active treatment (4 weeks).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BRS201
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Chestnut Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2023-12-12 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What NCT05835505 shows while recruiting
NCT05835505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05835505 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05835505 about?
NCT05835505 is a clinical study titled "Detoxification of the Liver In PSC (Dolphin)". 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...
What is the current status of trial NCT05835505?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2023-12-12. Estimated completion is 2026-12-01.
What conditions does trial NCT05835505 study?
This clinical trial studies the following conditions: Primary Sclerosing Cholangitis.
What interventions are being tested in trial NCT05835505?
The interventions under investigation include: Placebo (DRUG), BRS201 (DRUG).
Who is sponsoring clinical trial NCT05835505?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05835505 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Sclerosing Cholangitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05835505's enrollment target sits among peer trials
28 18th of 23 higher than 5 of 23 other Primary Sclerosing Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Sclerosing Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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-
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