The cause of PSC is unknown.To date, there is no treatment besides liver transplantation proven to improve PSC prognosis. However, there is a clear medical unmet need yet for patients with PSC, due to risks and complications of liver transplantation.
This is a two-part, Phase 2b, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of HK-660S in patients with PSC.
The primary objective is to evaluate the effects of HK-660S on serum ALP improvement (reduction of 20% or more) over 12 weeks of treatment in patients with PSC.
Male or female subjects aged ≥ 18 years.
Subjects and their sexual partner(s) who do not plan to become pregnant and agree to use at least one effective, appropriate contraceptive method (defined below) during the study period and up to 30 days after the last dosing of study drug
Contraception method: 1) hormonal contraceptives, 2) intrauterine contraceptive device or implantation of intrauterine system, 3) double-barrier method (combined use of spermicides and condoms, diaphragm, contraceptive sponge, or FemCap), or 4) sterilization (e.g., vasectomy, tubal ligation)
Women who are post-menopausal (have amenorrhea for 12 months or over 6 weeks after bilateral oophorectomy) and unlikely to become pregnant
Subjects with an average alcohol intake of more than 20g per day within 2 years prior to screening.
Subjects who have a diagnosis of type 1 diabetes or uncontrolled type 2 diabetes (HbA1c ≥ 9%) prior to screening.
Subjects who have chronic liver diseases other than PSC: non-alcoholic fatty liver disease, viral chronic hepatitis, alcoholic liver disease, primary biliary liver cholangitis, biliary obstruction, autoimmune hepatitis, hemoglobin deposition, Wilson's disease, α-1 antitrypsin deficiency, etc.
Subjects who have a diagnosis of primary biliary cholangitis or secondary sclerosing cholangitis in MRCP or ERCP prior to screening.
Parallel
HK-660S 100mg
DrugAdministered orally
HK-660S 200mg
DrugAdministered orally
Placebo
DrugAdministered orally
Percentage of subjects who show improvement of ALP
The improvement of ALP is defined as 20% or more ALP reduction
Percentage of subjects who show improvement of severity of PSC
The improvement of severity is defined as a decrease of -1 or more in the MRCP Anali score
Percentage of subjects who show improvement of bile duct strictures in MRCP
Defined as improvement (absence or improvement) in at least one of bile strictures, dilatation or bile ductal wall thickening and enhancement based on the IPSCSG (International Primary Sclerosing Cholangitis Study Group) MRI Reporting Guideline.
Percentage of subjects who show 50% or more reduction of ALP
Percentage of subjects who show ALP normalization or partial normalization (< 1.5 x ULN)
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This trial is not recruiting at the moment. You can still explore other options:
