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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Primary Sclerosing Cholangitis
Intervention / Treatment

-

Contacts and Locations

Redwood City

Stanford Clinic, Redwood City, California, United States, 94063

Stanford

Stanford Clinic, Stanford, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

14 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aparna Goel,

Aparna Goel, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Leina Alrabadi, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2025-05