Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Phase 2 · Testing Hymecromone · 2 sites · Aparna Goel
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Hymecromone (a drug) as a possible treatment. Condition(s) listed: Primary Sclerosing Cholangitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 14 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 24 participants are expected to take part.
- The study has 2 groups.
- Start date: 2023-05-10.
- Main results expected around 2027-05 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in United States.
Groups in this study
- Hymecromone (listed as: experimental group)
- Standard Of Care (SOC) (listed as: no-intervention group)
Main thing being measured
- Change in serum gamma-glutamyltransferase (GGT) levels (Baseline to Month 6)
In the researchers’ words
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…
Words you might see
- ALP (alkaline phosphatase): a liver blood test that is often high in PSC.
- Cholangiocarcinoma: cancer of the bile ducts.
- Fecal calprotectin: a stool test that measures inflammation in the gut.
- Endoscopy: a camera exam inside the digestive tract.
- Mayo score: a score used to measure how active ulcerative colitis is.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
- Biopsy / histology: a small tissue sample examined under a microscope.
- Liver stiffness (elastography): a scan that estimates liver scarring.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Primary Sclerosing Cholangitis |
| Lead sponsor | Aparna Goel |
| Enrollment | 24 (estimated) |
| Start date | 2023-05-10 |
| Primary completion (est.) | 2027-05 |
| First posted | 2022-03-25 |
| Last updated | 2025-06-13 |
| Official title | A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study). |
| ClinicalTrials.gov ID | NCT05295680 |
Interventions
- Hymecromone (Drug)
Hymecromone 400 mg 3 times daily by mouth.
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford Clinic | Redwood City, California | United States | Recruiting |
| Stanford Clinic | Stanford, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.