NCT05295680: HAAPS

A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).

Recruiting now Phase 2 Last updated 11 June 2025

What this trial tests

Phase 2 trial testing Hymecromone in Primary Sclerosing Cholangitis in 24 participants. Currently enrolling.

Timeline

10 May 2023

Primary endpoint
1 May 2027

1 December 2027

Quick facts

Lead sponsor	Aparna Goel
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	10 May 2023
Primary completion	1 May 2027
Estimated completion	1 December 2027
Sites	2 locations across United States

Drugs / interventions tested

• Hymecromone (HYMECROMONE) — full drug profile →

Conditions studied

• Primary Sclerosing Cholangitis — all drugs for Primary Sclerosing Cholangitis →

Sponsor

Aparna Goel

Who can join

Adults 14 to 75, any sex, with Primary Sclerosing Cholangitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in serum gamma-glutamyltransferase (GGT) levels
  Time frame: Baseline to Month 6

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Compressive stresses in cancer: characterization and implications for tumour progression and treatment.
   Linke JA, Munn LL, Jain RK. · · 2024 · cited 46× · PMID 39390249 · DOI 10.1038/s41568-024-00745-z
2. Fibroblasts in liver cancer: functions and therapeutic translation.
   Affo S, Filliol A, Gores GJ, Schwabe RF. · · 2023 · cited 34× · PMID 37385282 · DOI 10.1016/s2468-1253(23)00111-5
3. Bile Acids-Based Therapies for Primary Sclerosing Cholangitis: Current Landscape and Future Developments.
   Fiorucci S, Urbani G, Di Giorgio C, Biagioli M, et al · · 2024 · cited 9× · PMID 39404413 · DOI 10.3390/cells13191650
4. Strategies to Overcome Intrinsic and Acquired Resistance to Chemoradiotherapy in Head and Neck Cancer.
   de Bakker T, Maes A, Dragan T, Martinive P, et al · · 2024 · cited 5× · PMID 39791719 · DOI 10.3390/cells14010018
5. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next?
   Salman L, Martinez L, Faddoul G, Manning C, et al · · 2023 · cited 2× · PMID 37055910 · DOI 10.34067/kid.0000000000000126
6. A novel clinical trial for primary sclerosing cholangitis from Asia: All regional endeavors should improve global management of primary sclerosing cholangitis: Editorial on "Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind
   Komori A. · · 2025 · cited 1× · PMID 39501575 · DOI 10.3350/cmh.2024.0945