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NCT05295680 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Aparna Goel.

Recruiting
Registry status
Phase 2
Development phase
24
Enrollment target
2
Study locations

NCT05295680 is a Phase 2 study of Primary Sclerosing Cholangitis that is actively recruiting participants, run by Aparna Goel. The registered enrollment target is 24 participants, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT05295680, a Phase 2 study of Primary Sclerosing Cholangitis, is actively recruiting participants, sponsored by Aparna Goel.

RECRUITING
Registry status
Phase 2
Development phase
24 participants
Enrollment target
2
Study locations

Study Summary

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.

Interventions

  • DRUG Hymecromone

Study Locations (2)

California

  • Stanford Clinic - Redwood City
  • Stanford Clinic - Stanford

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2023-05-10
Est. Completion 2027-12
Phase Phase 2

Sponsor

Aparna Goel

1 total trials

What the Registry Record Tells You About NCT05295680

The ClinicalTrials.gov registry entry for NCT05295680 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 552-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (96% lower). The listed sponsor is Aparna Goel, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 1 intervention - of which Hymecromone is the first listed.

NCT05295680 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05295680 about?

NCT05295680 is a clinical study titled "Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.". 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 m...

What is the current status of trial NCT05295680?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2023-05-10. Estimated completion is 2027-12.

What conditions does trial NCT05295680 study?

This clinical trial studies the following conditions: Primary Sclerosing Cholangitis.

What interventions are being tested in trial NCT05295680?

The interventions under investigation include: Hymecromone (DRUG).

Who is sponsoring clinical trial NCT05295680?

This trial is sponsored by Aparna Goel, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05295680 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.