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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05835505
The ClinicalTrials.gov registry entry for NCT05835505 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (95% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.