Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
ConditionPrimary Sclerosing Cholangitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-75
SponsorAparna Goel
About this trial
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
Qualifiers
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
Disqualifiers
Currently receiving biologic therapies
Known allergy to hymecromone
Cholangiocarcinoma
Pregnancy
Trial design
Treatments tested in this trial
- Hymecromone
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Aparna Goel
Lead sponsor
Stanford University
Sponsor institution
Source ClinicalTrials.gov