A Study of Oral Hymecromone to Treat Adults With Primary Sclerosing Cholangitis
| Status: | Withdrawn |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | October 2018 |
| End Date: | September 2020 |
A Pilot Study of Oral Hymecromone to Treat Adults With Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary ducts
in the liver resulting in destruction and fibrosis. PSC is associated with increased serum
levels of hyaluronan (HA), an extracellular matrix polymer known to drive inflammation in
multiple other tissues and disease models. Inhibition of HA synthesis with oral hymecromone
has been shown to prevent progression of autoimmunity in several animal models. This is a
prospective, open-label, single-center, pilot safety study of hymecromone in adults 18 years
of age or older diagnosed with primary sclerosing cholangitis without evidence of hepatic
fibrosis. Participants will be treated for 6 months with study drug. Safety and biomarkers of
response will be monitored during therapy.
in the liver resulting in destruction and fibrosis. PSC is associated with increased serum
levels of hyaluronan (HA), an extracellular matrix polymer known to drive inflammation in
multiple other tissues and disease models. Inhibition of HA synthesis with oral hymecromone
has been shown to prevent progression of autoimmunity in several animal models. This is a
prospective, open-label, single-center, pilot safety study of hymecromone in adults 18 years
of age or older diagnosed with primary sclerosing cholangitis without evidence of hepatic
fibrosis. Participants will be treated for 6 months with study drug. Safety and biomarkers of
response will be monitored during therapy.
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and/or imaging
study (MRI cholangiography or endoscopic retrograde cholangiopancreatography)
- Gamma-glutamyl transferase (GGT) and Alkaline phosphatase >1.5 times the upper limit
of normal
- If history of endoscopically confirmed inflammatory bowel disease, currently stable
based on Harvey-Bradshaw index ≤ 2, normal inflammatory markers (ESR, C-reactive
protein, and fecal calprotectin) and stable non-excluded medical therapy for at least
6 months.
- Not currently taking vancomycin for at least 3 months prior to enrollment. Patients on
vancomycin can stop for 3 months and then be screened for enrollment.
- Not currently taking ursodiol for at least 3 months prior to enrollment. Patients on
ursodiol can stop for 3 months and then be screened for enrollment.
Exclusion Criteria:
- Currently receiving biologic therapies (i.e. infliximab, adalimumab, golimumab, etc.)
or steroid medications for inflammatory bowel disease
- Known allergy to hymecromone
- Established hepatic or biliary fibrosis
- Cholangiocarcinoma
- Pregnancy
- Physician concern that participant may not adhere to the study protocol, based on
prior behavior
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