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

Launched by APARNA GOEL · Mar 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called hymecromone to see if it can help treat adolescents and adults with a liver condition known as primary sclerosing cholangitis (PSC). The main goal is to find out if taking hymecromone along with standard treatment is more effective than just using standard treatment alone. Researchers will also look at how hymecromone affects certain liver-related blood tests and other markers of disease over a period of six months.

To participate in this trial, individuals must be diagnosed with PSC, confirmed by a liver biopsy or imaging test. They should also be stable if they have inflammatory bowel disease. However, people who are currently taking biologic therapies, have a known allergy to hymecromone, have a specific type of bile duct cancer, are pregnant, or have severe liver disease are not eligible. Those who join the study can expect regular check-ups and tests to monitor their condition and the effects of the medication. The trial is currently looking for participants of all genders aged between 11 and 39.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Colitis Score ≤ 1, normal inflammatory markers (ESR, CRP and fecal calprotectin) and stable non-excluded medical therapy for at least 6 months
• Exclusion Criteria:
• • Currently receiving biologic therapies
• • Known allergy to hymecromone
• • Cholangiocarcinoma
• • Pregnancy
• • Serious liver disease