Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hymecromone.
- Who it may be relevant to
- Registry conditions: Primary Sclerosing Cholangitis. Basic parameters: 14 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS 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.
Interventions
- Drug Hymecromone
Hymecromone 400 mg 3 times daily by mouth.
Primary outcome measures
- Change in serum gamma-glutamyltransferase (GGT) levels [Time frame: Baseline to Month 6]
Secondary outcome measures (10)
- 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 [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 [Time frame: Baseline to Month 6]
- Change in lymphocyte immunophenotype [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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Stanford Clinic — Redwood City
- Stanford Clinic — Stanford
Publications
- Salman L, Martinez L, Faddoul G, Manning C, Ali K, Salman M, Vazquez-Padron R. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next? Kidney360. 2023 Jun 1;4(6):e851-e860. doi: 10.34067/KID.0000000000000126. Epub 2023 Apr 14. PMID 37055910
Identifiers
NCT: NCT05295680 · 64030