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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 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.

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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.

Interventions

  • DRUG Placebo
  • DRUG Sulfasalazine

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Chestnut Hill

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2018-07-01
Est. Completion 2026-03-03
Phase Phase 2

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT03561584

The ClinicalTrials.gov registry entry for NCT03561584 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 551-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (94% 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.

NCT03561584 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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