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

Aparna Goel

Status and phase: Enrolling; Phase 2

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: Hymecromone

Study type: Interventional

Funder types: Other

Identifiers

NCT05295680

64030

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Hymecromone

Experimental group

Description:

Participants will receive Hymecromone for six months + Standard Of Care (SOC), and will be followed for an additional nine months.

Treatment:

Drug: Hymecromone

Standard Of Care (SOC)

No Intervention group

Description:

Participants will receive Standard Of Care (SOC), and will be followed for 15 months.