Recruiting
Phase 2

Hymecromone

Sponsor:

Aparna Goel

Code:

NCT05295680

Conditions

Primary Sclerosing Cholangitis

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Interventions

Hymecromone

Study Details

Brief 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

Study ID

NCT05295680

Start date

May 10, 2023

Status verified date

Nov, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hymecromone

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

no intervention: Standard Of Care (SOC)

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

Interventions

Hymecromone

Hymecromone 400 mg 3 times daily by mouth.

Primary outcome measure

  • Change in serum gamma-glutamyltransferase (GGT) levels [ Time Frame: Baseline to Month 6 ]

Central Contacts and Locations

Locations

Stanford Clinic

Recruiting

Redwood City, California, United States, 94063

Contacts

Aparna Goel, MD

(650) 498-7878goela21@stanford.edu

Stanford Clinic

Recruiting

Stanford, California, United States, 94305

Contacts

Leina Alrabadi, MD

(650) 721-2250alrabadi@stanford.edu

More Information

Sponsor

Aparna Goel

Last update posted

Jun 13, 2025

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aparna Goel on 2025-06-13.