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

NCT02293941 | Terminated Phase 2 DMC

• 1 other identifier: JKB122
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 14

Brief 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

Keywords

liver inflammation

Outcome Measures

Primary Outcomes (1)

• ALT

  To assess changes in ALT in HCV-infected subjects given daily doses of JKB-122

  baseline and 12 weeks

Secondary Outcomes (2)

• Pharmacokinetic analysis (plasma concentration of JKB-122)

  Day 1, 29, 57, 78

• Clinical laboratory tests (Includes hematology, coagulation, and serum chemistry.)

  Screening, Day 1, 15, 29, 57, 85 and 30 days after EOS

Study Arms (4)

JKB-122 5mg

EXPERIMENTAL

5mg, oral, once daily

Drug: JKB-122 5mg

JKB-122 15 mg

EXPERIMENTAL

15mg, oral, once daily

Drug: JKB-122 15mg

JKB-122 35 mg

EXPERIMENTAL

35mg, oral, once daily

Drug: JKB-122 35mg

placebo

PLACEBO COMPARATOR

comparable capsule, oral, once daily

Drug: Placebo

Interventions

JKB-122 5mg DRUG

Participants were randomized to receive JKB-122 5mg for 12 weeks

JKB-122 5mg

JKB-122 15mg DRUG

Participants were randomized to receive JKB-122 15mg for 12 weeks

JKB-122 15 mg

JKB-122 35mg DRUG

Participants were randomized to receive JKB-122 35mg for 12 weeks

JKB-122 35 mg

Placebo DRUG

Participants were randomized to receive comparable placebo for 12 weeks

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is HCV positive (documented by HCV RNA testing at Screening). Chronic hepatitis C is defined as a) Positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA and anti-HCV antibody at the time of screening; or b) Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis), according to "Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment".
• Has previous results from HCV genotype testing. If previous results are not available, such testing should be performed at Screening.
• Has had a liver biopsy or Fibroscan™ within 3 years and the severity of hepatic dysfunction is limited to the following:
• Metavir Stage 0 to stage 3 fibrosis (according to liver biopsy) or Fibroscan™ results
• ALT and AST values not exceeding 5 x ULN (Baseline value for each parameter will be calculated as the average of 3 values obtained 7 days apart
• Normal total bilirubin, and prothrombin time/INR values
• Has elevated liver test results (ALT) at least 1.5 x ULN and not exceeding 5 x ULN (Baseline value for each parameter will be calculated as the average of 3 values obtained 7 days apart
• Is refractory or null responder, intolerable, relapser, or partial responder.
• Null responder is defined as less than a 2 log10 IU/mL reduction in HCV RNA after 12 weeks of treatment with standard or Peg Interferon/ribavirin or other anti-HCV therapies;
• Relapser is defined as HCV RNA undetectable (or negative, per site's definition) at the end stage of treatment with a standard or pegylated interferon-based regimen or other anti-HCV therapies, but HCV RNA detectable during post-treatment follow-up;
• The intolerable is defined as HCV patients who cannot tolerate the side effects of previous interferon-based therapies or other anti-HCV therapies, or who were not suitable for interferon-based therapies or other anti-HCV therapies;
• Partial responder is defined as achieved more than 2 log10 IU/mL reduction in HCV RNA by Week 12 (± 1 week) during a prior pegIFN/RBV treatment course or other anti-HCV therapies but failed to achieve HCV RNA undetectable at the end stage of treatment.

You may not qualify if:

• Has history of allergy to JKB-122 or related compounds
• Has human immunodeficiency virus (HIV) or is hepatitis B positive
• Is with a current diagnosis of cirrhosis, both compensated and uncompensated Child-Pugh A, B or C
• Has positive urine drug screen at Screening
• Is currently consuming greater than 30 g of alcohol per day (eg, 2 highballs with 1 shot each, or 2 beers) or has consumed greater than 2 glasses of alcohol per day within 3 months prior to the first screening visit (Day -28)
• Is being treated with any prescription narcotic drug (including transdermal delivery systems)
• Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
• Has unstable and uncontrollable hypertension (\>180/110 mmHg)
• Has received other therapies for HCV infection (interferon, pegylated interferon, ribavirin, or others) in the last 4 weeks prior to the first screening visit (Day -28)
• Requires concomitant use of or treatment with opioids or other excluded drugs such as hepatotoxic medications
• Has received other investigational agents within 30 days prior to the first screening visit (Day -28)
• Has a disease that would require chronic use of prescription corticosteroids
• Has either autoimmune or genetic liver disease
• May be chronically or latently infected with microbial agents other than HCV
• Has impaired renal function

Sponsors & Collaborators

• TaiwanJ Pharmaceuticals Co., Ltd: lead

Study Sites (14)

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Chiayi City, 622, Taiwan

Location

Chang Gung Memorial Hospital, Chiayi

Chiayi City, Taiwan

Location

Chia-Yi Christian Hospital

Chiayi City, Taiwan

Location

Chang Gung Memorial Hospital, Kaohsiung

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital, Keelung

Keelung, Taiwan

Location

Chi Mei Medical Center - Liouying Branch

Tainan, 736, Taiwan

Location

Chi Mei Hospital, YongKang Branch

Tainan, Taiwan

Location

Cathay General Hospital

Taipei, 280, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

China Medical University Beigang Hospital

Yuanlin, 651, Taiwan

Location

National Taiwan University Hospital, Yun-Lin Branch

Yuanlin, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis

Interventions

JKB-122

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ying-Chu Shih, PhD

  TaiwanJ Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 19, 2014
• Study Start: May 1, 2014
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

TW (14)