NCT05295680

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

A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Aparna Goel · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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. To evaluate changes in biomarkers of PSC disease during hymecromone treatment, namely: (a) fibrotic effect (FibroScan); (b) inflammatory biomarkers (serum Hyaluronan (HA)); and, (c) T-cell count.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	Hymecromone	Hymecromone 400 mg 3 times daily by mouth.

Timeline

• Start date: 2023-05-10
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2022-03-25
• Last updated: 2025-06-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study