Recruiting PHASE2 Primary Sclerosing Cholangitis

New treatment option for Primary Sclerosing Cholangitis

Official title Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.

ClinicalTrials.gov ID: NCT05295680

What this study is testing

What is Hymecromone?

Hymecromone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary sclerosing cholangitis.

Also referred to as Isochol.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Primary objective: To evaluate the efficacy of hymecromone plus standard of care compared with standard of care alone in the treatment of adolescents and adults with primary sclerosing cholangitis (PSC). Secondary objectives: To evaluate the change in Alkaline Phosphatase (ALP) from baseline to 6 months post-treatment following treatment with hymecromone plus standard of care compared with standard of care.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 14 to 75

You may be able to join if

  • Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and/or imaging study
  • If history of endoscopically confirmed inflammatory bowel disease, currently stable based on Mayo Score / Disease Activity Index (DAI) for Ulcerative...

You likely can't join if

  • Currently receiving biologic therapies
  • Known allergy to hymecromone
  • Cholangiocarcinoma
  • Pregnancy
  • Serious liver disease

The study team makes the final eligibility decision.

Where it's taking place

  • Redwood City, California, United States
  • Stanford, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 14 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Redwood City, California, United States; Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.