A Phase 2 interventional study of Hymecromone in Primary Sclerosing Cholangitis, sponsored by Aparna Goel. Recruiting at 2 sites in United States. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Aparna Goel · Phase 2, Interventional, and Treatment
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.
149 studies on the registry are indexed under Cholangitis, Sclerosing; 39 are open to participants now.
This study's planned enrollment of 24 is below the median of 34 across 94 interventional studies indexed under Cholangitis, Sclerosing.
Browse Cholangitis, Sclerosing studies →This is the only study on the registry with Aparna Goel as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Hymecromone for six months + Standard Of Care (SOC), and will be followed for an additional nine months.
Drug: Hymecromone
Participants will receive Standard Of Care (SOC), and will be followed for 15 months.
Hymecromone 400 mg 3 times daily by mouth.
Also known as: Isochol
Change in serum gamma-glutamyltransferase (GGT) levels
Time frame: Baseline to Month 6
Change in serum Alkaline Phosphatase (ALP) levels
Time frame: Baseline to Month 6
Change in serum hyaluronan levels
Time frame: Baseline to Month 6
Change in T-cell count
Time frame: Baseline to Month 6
Change in fibrotic effect based on FibroScan
Fibrotic effect is the amount of liver with fatty change
Time frame: Baseline to Month 6
Change in biliary tree anatomy (e.g. strictures) based on FibroScan
Time frame: Baseline to Month 6
Change in serum inflammatory cytokine profile
This outcome measure will assess pro-inflammatory cytokines previously associated with biliary inflammation and other autoimmune diseases including IFNg, IL-6, and TNF.
Time frame: Baseline to Month 6
Change in lymphocyte immunophenotype
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.
Time frame: Baseline to Month 6
Plasma drug levels of 4-MU
Time frame: Single blood draw at baseline, week 2, and months 1, 3, and 6 study visits
Plasma drug levels of 4-MUG
Time frame: Single blood draw at baseline, week 2, and months 1, 3, and 6 study visits
Plasma drug levels of 4-MUS
Time frame: Single blood draw at baseline, week 2, and months 1, 3, and 6 study visits
Plan to share: No
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Studies of the drug tested here: Hymecromone