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NCT Number: NCT05295680

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

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.

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Key information

Conditions

Primary Sclerosing Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Clinic, Redwood City, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hymecromone

Drug

Hymecromone 400 mg 3 times daily by mouth.

Other names: Isochol

Primary outcomes

  1. Change in serum gamma-glutamyltransferase (GGT) levels

    Time frame: Baseline to Month 6

Secondary outcomes

  1. Change in serum Alkaline Phosphatase (ALP) levels

    Time frame: Baseline to Month 6

  2. Change in serum hyaluronan levels

    Time frame: Baseline to Month 6

  3. Change in T-cell count

    Time frame: Baseline to Month 6

  4. Change in fibrotic effect based on FibroScan

    Time frame: Baseline to Month 6

    Fibrotic effect is the amount of liver with fatty change

  5. Change in biliary tree anatomy (e.g. strictures) based on FibroScan

    Time frame: Baseline to Month 6

  6. Change in serum inflammatory cytokine profile

    Time frame: Baseline to Month 6

    This outcome measure will assess pro-inflammatory cytokines previously associated with biliary inflammation and other autoimmune diseases including IFNg, IL-6, and TNF.

  7. Change in lymphocyte immunophenotype

    Time frame: Baseline to Month 6

    Single cell analysis technique will be used to assess the lymphocytes (B- and T-cells) present in serum samples, including FoxP3+ regulatory T-cells, a tolerogenic lymphocyte subset with important roles in immune tolerance.

  8. Plasma drug levels of 4-MU

    Time frame: Single blood draw at baseline, week 2, and months 1, 3, and 6 study visits

  9. Plasma drug levels of 4-MUG

    Time frame: Single blood draw at baseline, week 2, and months 1, 3, and 6 study visits

  10. Plasma drug levels of 4-MUS

    Time frame: Single blood draw at baseline, week 2, and months 1, 3, and 6 study visits

Sponsors and collaborators

Lead sponsor

Aparna Goel

Other

Registry information

Official study title

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

Acronym: HAAPS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2022
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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