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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Hymecromone

    Drug

    Hymecromone 400 mg 3 times daily by mouth.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: HymecromoneExperimental treatment 1 intervention
Group B: Standard Of Care (SOC)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in serum gamma-glutamyltransferase (GGT) levels

Time frame
Baseline to Month 6

Secondary outcomes

1

Change in serum Alkaline Phosphatase (ALP) levels

Time frame
Baseline to Month 6
2

Change in serum hyaluronan levels

Time frame
Baseline to Month 6
3

Change in T-cell count

Time frame
Baseline to Month 6
4

Change in fibrotic effect based on FibroScan

Fibrotic effect is the amount of liver with fatty change

Time frame
Baseline to Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aparna Goel

Lead sponsor

Stanford University

Sponsor institution

Source ClinicalTrials.gov
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