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

NCT02293941 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-07-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • TaiwanJ Pharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ying-Chu Shih, PhD · TaiwanJ Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-08-30
Completion
2017-08-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293941 on ClinicalTrials.gov