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Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.

Trial ID or NCT#

NCT05295680

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).

Eligibility Criteria

Ages Eligible for Study: 14 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * Currently receiving biologic therapies* Known allergy to hymecromone* Cholangiocarcinoma* Pregnancy* Serious liver disease
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Investigator(s)

Leina Alrabadi
Aparna Goel
Hepatologist, Transplant hepatologist
Clinical Associate Professor, Medicine - Gastroenterology & Hepatology
Natalie Torok
Natalie Torok
Hepatologist, Liver transplantation specialist, Transplant hepatologist
Professor of Medicine (Gastroenterology and Hepatology)

Contact us to find out if this trial is right for you.

Contact

SPECTRUM
650-498-6060

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