Background/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. Conclusions 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).

Background/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. Conclusions 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).

Background/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. Conclusions 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).

Objectives: This study explored the stigma and mental health challenges that vulnerable populations faced during COVID-19 using in-depth interviews with 32 participants. Methods: A generic qualitative methodology was employed, with data collected via face-to-face and Zoom interviews conducted from March to August 2021. Results: Two major themes emerged: the nature of stigmatization and mental health impacts.The participants reported increased exposure to personal information, worsening institutional stigmatization, and routine social exclusion, leading to internalized stigma. They experienced extreme fear, anxiety, depression, hopelessness, suicidal thoughts, and declining physical health. Conclusion The results underscore the necessity of a comprehensive mental health support system that integrates psychological interventions, stigma prevention education, anti-stigma initiatives, and customized policies. Future research should investigate the prolonged impact of pandemic-induced stigma and devise effective strategies for support and intervention.

Objectives: This study explored the stigma and mental health challenges that vulnerable populations faced during COVID-19 using in-depth interviews with 32 participants. Methods: A generic qualitative methodology was employed, with data collected via face-to-face and Zoom interviews conducted from March to August 2021. Results: Two major themes emerged: the nature of stigmatization and mental health impacts.The participants reported increased exposure to personal information, worsening institutional stigmatization, and routine social exclusion, leading to internalized stigma. They experienced extreme fear, anxiety, depression, hopelessness, suicidal thoughts, and declining physical health. Conclusion The results underscore the necessity of a comprehensive mental health support system that integrates psychological interventions, stigma prevention education, anti-stigma initiatives, and customized policies. Future research should investigate the prolonged impact of pandemic-induced stigma and devise effective strategies for support and intervention.

Objectives: This study explored the stigma and mental health challenges that vulnerable populations faced during COVID-19 using in-depth interviews with 32 participants. Methods: A generic qualitative methodology was employed, with data collected via face-to-face and Zoom interviews conducted from March to August 2021. Results: Two major themes emerged: the nature of stigmatization and mental health impacts.The participants reported increased exposure to personal information, worsening institutional stigmatization, and routine social exclusion, leading to internalized stigma. They experienced extreme fear, anxiety, depression, hopelessness, suicidal thoughts, and declining physical health. Conclusion The results underscore the necessity of a comprehensive mental health support system that integrates psychological interventions, stigma prevention education, anti-stigma initiatives, and customized policies. Future research should investigate the prolonged impact of pandemic-induced stigma and devise effective strategies for support and intervention.

Objectives: This study explored the stigma and mental health challenges that vulnerable populations faced during COVID-19 using in-depth interviews with 32 participants. Methods: A generic qualitative methodology was employed, with data collected via face-to-face and Zoom interviews conducted from March to August 2021. Results: Two major themes emerged: the nature of stigmatization and mental health impacts.The participants reported increased exposure to personal information, worsening institutional stigmatization, and routine social exclusion, leading to internalized stigma. They experienced extreme fear, anxiety, depression, hopelessness, suicidal thoughts, and declining physical health. Conclusion The results underscore the necessity of a comprehensive mental health support system that integrates psychological interventions, stigma prevention education, anti-stigma initiatives, and customized policies. Future research should investigate the prolonged impact of pandemic-induced stigma and devise effective strategies for support and intervention.