NCT05295680 Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
| NCT ID | NCT05295680 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Aparna Goel |
| Condition | Primary Sclerosing Cholangitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2023-05-10 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Aparna Goel, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05295680 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 75 Years, studying Primary Sclerosing Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05295680 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05295680 currently recruiting?
Yes, NCT05295680 is actively recruiting participants. Visit ClinicalTrials.gov or contact Aparna Goel to inquire about joining.
Where is the NCT05295680 trial being conducted?
This trial is being conducted at Redwood City, United States, Stanford, United States.
Who is sponsoring the NCT05295680 clinical trial?
NCT05295680 is sponsored by Aparna Goel. The principal investigator is Aparna Goel, MD at Stanford University. The trial plans to enroll 24 participants.