Status:
TERMINATED
Liver Test Study of Using JKB-122 in Hepatitis C Virus (HCV)-Positive Patients Nonresponsive to Prior Interferon Based Therapies
Lead Sponsor:
TaiwanJ Pharmaceuticals Co., Ltd
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 nonrespo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Has BMI\> 30 or BMI \<18
- If female, pregnant or lactating
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2017
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02293941
Start Date
May 1 2014
End Date
August 30 2017
Last Update
July 21 2020
Active Locations (14)
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1
Changhua Christian Hospital
Changhua, Taiwan, 500
2
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Chiayi City, Taiwan, 622
3
Chang Gung Memorial Hospital, Chiayi
Chiayi City, Taiwan
4
Chia-Yi Christian Hospital
Chiayi City, Taiwan