YUHSpace

BROWSE

Export
0 18

Cited 0 times in

Cited 0 times in

Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial

DC Field Value Language
dc.contributor.author정문재-
dc.date.accessioned2026-01-29T06:25:16Z-
dc.date.available2026-01-29T06:25:16Z-
dc.date.issued2025-01-
dc.identifier.issn2287-2728-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/210323-
dc.description.abstract10.3350/cmh.2024.0629-
dc.description.statementOfResponsibilityAdult ; Alkaline Phosphatase / blood ; Cholangiopancreatography, Magnetic Resonance ; Cholangitis, Sclerosing* / diagnosis ; Cholangitis, Sclerosing* / drug therapy ; Cholangitis, Sclerosing* / pathology ; Double-Blind Method ; Female ; Humans ; Liver / diagnostic imaging ; Liver / pathology ; Male ; Middle Aged ; Severity of Illness Index ; Treatment Outcome-
dc.languageEnglish-
dc.publisherKorean Association for the Study of the Liver-
dc.relation.isPartOfCLINICAL AND MOLECULAR HEPATOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAlkaline phosphatase-
dc.subject.MESHCholangiopancreatography, magnetic resonance-
dc.subject.MESHLapachone-
dc.subject.MESHNicotinamide adenine dinucleotide-
dc.subject.MESHPrimary sclerosing cholangitis-
dc.titleSafety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorWoo Hyun Paik-
dc.contributor.googleauthorJoo Kyung Park-
dc.contributor.googleauthorMoon Jae Chung-
dc.contributor.googleauthorGunn Huh-
dc.contributor.googleauthorCe Hwan Park-
dc.contributor.googleauthorSang Hyub Lee-
dc.contributor.googleauthorHeon Se Jeong-
dc.contributor.googleauthorHee Jin Kim-
dc.contributor.googleauthorDo Hyun Park-
dc.identifier.doi39314133-
dc.contributor.localIdA03602-
dc.relation.journalcodeJ00557-
dc.identifier.eissn2287-285X-
dc.subject.keywordBackground/aims: A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events. Results: The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated. Conclusion: HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).-
dc.contributor.alternativeNameChung, Moon Jae-
dc.contributor.affiliatedAuthor정문재-
dc.citation.volume31-
dc.citation.number1-
dc.citation.startPage119-
dc.citation.endPage130-
dc.identifier.bibliographicCitationCLINICAL AND MOLECULAR HEPATOLOGY, Vol.31(1) : 119-130, 2025-01-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Show simple item record Find it @ YMLIB

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

  • License
    sherpa_romeo
    sherpa_juliet

OAK

DSpace Software Copyright © 2002-2017 Duraspace Yonsei University Medical Library All right Reserves. / TEL:02-2228-2915 /
YUHSpace는 국립중앙도서관 OAK 보급사업으로 구축되었습니다.

Browse

Links