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Oral Hymecromone for Primary Sclerosing Cholangitis (HAAPS Trial)

Phase 2

Recruiting

Led By Leina Alrabadi, MD

Research Sponsored by Aparna Goel

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and/or imaging study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up single blood draw at baseline, week 2, and months 1, 3, and 6 study visits

Awards & highlights

HAAPS Trial Summary

This trial is testing a new treatment for primary sclerosing cholangitis (PSC), a liver disease. The new treatment is a drug called hymecromone, which is being given with standard care (the current best treatment). The trial will see if hymecromone plus standard care is better than standard care alone at improving a liver function test called ALP, and also at reducing biomarkers of PSC disease.

Who is the study for?

This trial is for adolescents and adults with confirmed primary sclerosing cholangitis (PSC). Participants should have stable inflammatory bowel disease if present, normal inflammation markers, and consistent non-excluded medication for at least 6 months. Those on biologics, pregnant individuals, people with serious liver issues or cholangiocarcinoma, or allergies to hymecromone can't join.Check my eligibility

What is being tested?

The study tests the effectiveness of hymecromone added to standard care versus standard care alone in treating PSC. It will measure changes in liver enzymes (ALP), fibrosis via FibroScan, serum Hyaluronan levels indicating inflammation, and T-cell counts over a period of six months.See study design

What are the potential side effects?

While specific side effects are not listed here, hymecromone could potentially cause digestive upset or allergic reactions in those sensitive to it. Monitoring during the trial would capture any other adverse effects.

HAAPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My liver condition was confirmed by a biopsy or imaging.

HAAPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ single blood draw at baseline, week 2, and months 1, 3, and 6 study visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~single blood draw at baseline, week 2, and months 1, 3, and 6 study visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and single blood draw at baseline, week 2, and months 1, 3, and 6 study visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in serum gamma-glutamyltransferase (GGT) levels

Secondary outcome measures

Change in T-cell count

Change in biliary tree anatomy (e.g. strictures) based on FibroScan

Change in fibrotic effect based on FibroScan

+7 more

HAAPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HymecromoneExperimental Treatment1 Intervention

Participants will receive Hymecromone for six months + Standard Of Care (SOC), and will be followed for an additional nine months.

Group II: Standard Of Care (SOC)Active Control1 Intervention

Participants will receive Standard Of Care (SOC), and will be followed for 15 months.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aparna GoelLead Sponsor

Paul BollykyLead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

Leina Alrabadi, MDPrincipal InvestigatorStanford University

Media Library

Hymecromone (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05295680 — Phase 2

Primary Sclerosing Cholangitis Research Study Groups: Hymecromone, Standard Of Care (SOC)

Primary Sclerosing Cholangitis Clinical Trial 2023: Hymecromone Highlights & Side Effects. Trial Name: NCT05295680 — Phase 2

Hymecromone (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05295680 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial extend to younger cohorts under 25 years of age?

"The requirements for participation in this trial suggest that participants must be between 14 and 75 years old. Additionally, there are 4 studies dedicated to younger patients and 41 specifically aimed at elderly persons above the age of 65."

Answered by AI

Has the FDA sanctioned Hymecromone for human consumption?

"Due to the lack of documented evidence demonstrating Hymecromone's efficacy, this drug was assessed with a score of 2 in regards to safety."

Answered by AI

Who meets the criteria for participating in this medical research?

"This medical trial is admitting 24 people, aged between 14 and 75 with a confirmed diagnosis of primary sclerosing cholangitis. Furthermore, they must have had endoscopic confirmation of inflammatory bowel disease, be in an overall stable condition based on the Mayo Score / Disease Activity Index (DAI) for Ulcerative colitis Score ≤ 1, possess normal levels of ESR, CRP and fecal calprotectin markers as well as sustained non-prohibited treatments for at least 6 months."

Answered by AI

Is this trial actively searching for participants?

"The clinicaltrials.gov website informs us that recruitment for this particular study has been concluded as of November 1st, 2022. However, 42 other trials are actively looking for participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Aparna Goel 2023. "Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05295680.