The primary objective of this study is to assess changes in alanine aminotransferase (ALT) in hepatitis C virus (HCV)-infected subjects given daily doses of JKB-122 for 3 months who have been nonresponsive to, intolerable to, or relapsed from prior interferon-based therapies (pegylated or standard) either alone or in combination with ribavirin or other anti-HCV therapies including direct-acting anti-viral agents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Participants were randomized to receive JKB-122 5mg for 12 weeks
Participants were randomized to receive JKB-122 15mg for 12 weeks
Participants were randomized to receive JKB-122 35mg for 12 weeks
Changhua Christian Hospital
Changhua, Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Chiayi City, Taiwan
Chang Gung Memorial Hospital, Chiayi
Chiayi City, Taiwan
ALT
To assess changes in ALT in HCV-infected subjects given daily doses of JKB-122
Time frame: baseline and 12 weeks
Pharmacokinetic analysis (plasma concentration of JKB-122)
plasma concentration of JKB-122 will be measured for exploration of exposure/response relationships in all subjects of each dose group at Stage 1.
Time frame: Day 1, 29, 57, 78
Clinical laboratory tests (Includes hematology, coagulation, and serum chemistry.)
Includes hematology, coagulation, and serum chemistry.
Time frame: Screening, Day 1, 15, 29, 57, 85 and 30 days after EOS
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Participants were randomized to receive comparable placebo for 12 weeks
Chia-Yi Christian Hospital
Chiayi City, Taiwan
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital, Keelung
Keelung, Taiwan
Chi Mei Medical Center - Liouying Branch
Tainan, Taiwan
Chi Mei Hospital, YongKang Branch
Tainan, Taiwan
Cathay General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
...and 4 more locations