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BRS201 Arm for Primary Sclerosing Cholangitis (DOLPHIN Trial)

Phase 2

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

DOLPHIN Trial Summary

This trial will investigate an oral medication for treating a liver disease. Participants will take the drug and a placebo twice daily and have lab tests done at home.

Who is the study for?

This trial is for people who've had primary sclerosing cholangitis (PSC) for at least 6 months, confirmed by specific imaging tests. They should have a certain liver enzyme level above normal and if taking ursodeoxycholic acid, the dose must be stable for over 6 months or stopped more than 4 weeks before screening.Check my eligibility

What is being tested?

The study tests BRS201's effectiveness in treating PSC. It's an 8-week cross-over trial where participants take BRS201 and a placebo in random order for four weeks each as oral medication, possibly with an IV dose. There are nine remote visits involving blood draws and stool samples.See study design

What are the potential side effects?

Potential side effects aren't specified here but generally could include reactions to the drug or placebo like stomach upset, allergic reactions, changes in liver enzymes, fatigue or discomfort from blood draws.

DOLPHIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PSC for at least 6 months, confirmed by a specific bile duct scan.

DOLPHIN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alkaline Phosphatase (ALP) Test Result

DOLPHIN Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: BRS201 ArmActive Control1 Intervention

In Group 1 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) for 4 weeks. In Group 2 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) for 4 weeks. In Group 3 of the study, subjects will take receive a one-time 5g IV dose of the study drug using the FDA-approved IV product followed by the oral study drug at 2g twice daily, PO (4g daily) for 4 weeks. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.

Group II: Placebo ArmPlacebo Group1 Intervention

In Group 1 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) for 4 weeks. In Group 2 of the study, subjects will take oral placebo at 2g twice daily, PO (4g daily) for 4 weeks. In Group 3 of the study, subjects will take receive a one-time 5g IV dose of the study drug using the FDA-approved IV product followed by the oral placebo at 2g twice daily, PO (4g daily) for 4 weeks. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,920 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any spots left open for participants in this research?

"Right, according to official records posted on clinicaltrials.gov this study is currently in search of 28 volunteers from one location. It was originally made available for recruitment on December 12th 2023 and the most recent update took place that same day."

Answered by AI

Who qualifies to participate in this clinical trial?

"This clinical trial is welcoming 28 participants of primary sclerosing cholangitis, aged 18 to 75. To qualify for the study, patients must have had a diagnosis confirmed by ERCP or MRCP imaging showing biliary abnormalities associated with PSC., ALP higher than 1.5 times normal upper limit at screening., and either be prescribed ursodeoxycholic acid for more than 6 months before screening or stopped using it 4 weeks prior (with no more than 60% being UDCA users)."

Answered by AI

Are participants of age 35 and up eligible to join this trial?

"Those eligible to participate in this research must meet the age requirement of being 18 or older, yet under 75."

Answered by AI

What is the cap for enrolling participants in this study?

"Affirmative. Information accessible on clinicaltrials.gov indicates that this medical trial, initially posted on December 12th 2023, is recruiting patients at present. 28 participants are needed to be recruited from 1 particular location."

Answered by AI

Has the FDA sanctioned BRS201 Arm as a legitimate treatment option?

"BRS201 Arm received a score of 2 on our rating scale due to the presence of some data attesting to its safety, yet lack thereof concerning efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Detoxification of the Liver In PSC (Dolphin)

Joshua Korzenik 2023. "Detoxification of the Liver In PSC (Dolphin)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05835505.