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NCT03561584 · ClinicalTrials.gov registry record · Phase 2
Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis
A Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03561584: Completed Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Brigham and Women's Hospital.
NCT03561584 is a Phase 2 study of Primary Sclerosing Cholangitis that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 32 participants, below the 551-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03561584, a Phase 2 study of Primary Sclerosing Cholangitis, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a multicenter, randomized, double-blinded placebo controlled trial to assess the benefit of sulfasalazine in the treatment of PSC. The specific objectives of this study are to determine if sulfasalazine treatment 1) results in reduced serum ALP and other biomarkers of liver injury in PSC; 2) improves PSC patient symptoms; and 3) is safe in patients with PSC. We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.
Primary Outcome
Proportion of patients with reduction of mean ALP \< 1.5 x ULN at end of treatment
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sulfasalazine
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Chestnut Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2026-03-03 |
| Phase | Phase 2 |
What the finished NCT03561584 record still lists
NCT03561584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 551-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (94% 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.
NCT03561584 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03561584 about?
NCT03561584 is a clinical study titled "Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis". This is a multicenter, randomized, double-blinded placebo controlled trial to assess the benefit of sulfasalazine in the treatment of PSC. The specific objectives of this study are to determine if sulfasalazine treatment 1) results in reduced serum ALP and other biomarkers of liver injury in PSC; 2)...
What is the current status of trial NCT03561584?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2018-07-01. Estimated completion is 2026-03-03.
What conditions does trial NCT03561584 study?
This clinical trial studies the following conditions: Primary Sclerosing Cholangitis.
What interventions are being tested in trial NCT03561584?
The interventions under investigation include: Placebo (DRUG), Sulfasalazine (DRUG).
Who is sponsoring clinical trial NCT03561584?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03561584 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 NCT03561584's enrollment target sits among peer trials
32 16th of 23 higher than 8 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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