NCT02293941

Liver Test Study of Using JKB-122 in Hepatitis C Virus (HCV)-Positive Patients Nonresponsive to Prior Interferon Based Therapies

A Phase 2, Randomized, Multiple-dose, Double-blind, Placebo-controlled Study of JKB-122 to Assess Liver Tests in HCV Subjects Who Have Been Nonresponsive to Prior Interferon Based Therapies Either Alone or in Combination With Ribavirin

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: TaiwanJ Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	JKB-122 5mg	Participants were randomized to receive JKB-122 5mg for 12 weeks
DRUG	JKB-122 15mg	Participants were randomized to receive JKB-122 15mg for 12 weeks
DRUG	JKB-122 35mg	Participants were randomized to receive JKB-122 35mg for 12 weeks
DRUG	Placebo	Participants were randomized to receive comparable placebo for 12 weeks

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-08-30
• Completion: 2017-08-30
• First posted: 2014-11-19
• Last updated: 2020-07-21

Locations

14 sites across 1 country: Taiwan