A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis
brief summary
The primary objective of the study is to compare the changes in serum ALT level among patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg SNP-610 or the placebo. The secondary objectives will be to compare the changes in liver fat fraction, other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates among the interventional and placebo arms.
detailed description
A randomized, double-blind, placebo controlled study will be conducted in medical centers around Taiwan.
The objective of the study is to investigate the efficacy and safety of SNP-610 for the treatment of NASH, assuming the treatment efficacy of the investigational product is superior to the placebo control.
Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study. Eligible subjects will be randomized in a 1:1 ratio to receive study drug or placebo control. Considering a 10% drop-out rate, approximately 80 subjects will be enrolled in order to recruit 70 evaluable subjects, each arm will be at least 35 evaluable subjects to complete the enrollment.
Subjects will be administered the test drugs or placebo oral daily for 3 months or until treatment terminates prematurely. Subjects will return to the study center for clinical evaluation once every 4 weeks throughout the treatment period. Clinical assessment procedures and laboratory tests including ultrasound imaging, hematology with differential, biochemistry, liver function panel, and urinalysis, will be performed at each study visit. The primary endpoint assessment will be the reduction of ALT at completion of Week 12 treatment.
Subjects who finish treatment or discontinue prematurely from the study for any reason after receiving one or more doses of study drug will be assessed for safety for 2 (±1) weeks after the last study drug dose or longer in the case of any significant AE or abnormal biochemical or clinical finding.
Each subject will participate in the study for approximately 14 weeks (including the enrollment/baseline visit, 3 routine monthly visits during treatment period, and 1 follow-up visit after 2 weeks of the end of treatment).
It is assumed the study will include a 6 months enrollment period and a further 4 months to complete the follow-up for all enrolled patients.