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

Part of paid clinical trials in Redwood City, California.

Sponsor
Aparna Goel
Study ID
NCT05295680
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Primary Sclerosing Cholangitis

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Hymecromone — DRUG
    Hymecromone 400 mg 3 times daily by mouth.

Study Details

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.

Key Dates

Start date
May 10, 2023
Status verified
Nov 2024
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hymecromone
    Participants will receive Hymecromone for six months + Standard Of Care (SOC), and will be followed for an additional nine months.
  • No Intervention: Standard Of Care (SOC)
    Participants will receive Standard Of Care (SOC), and will be followed for 15 months.

Primary Outcome Measure

Change in serum gamma-glutamyltransferase (GGT) levels [ Time Frame: Baseline to Month 6 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford ClinicRedwood CityCalifornia94063
Aparna Goel, MD
[email protected]
(650) 498-7878
Stanford ClinicStanfordCalifornia94305
Leina Alrabadi, MD
[email protected]
(650) 721-2250

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