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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02293941
• Date of registration: 13/11/2014
• Prospective Registration: No
• Primary sponsor: TaiwanJ Pharmaceuticals Co., Ltd
• Public title: Liver Test Study of Using JKB-122 in Hepatitis C Virus (HCV)-Positive Patients Nonresponsive to Prior Interferon Based Therapies JKB122
• Scientific title: 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
• Date of first enrolment: May 2014
• Target sample size: 54
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02293941
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Taiwan, United States

Contacts

• Name: Ying-Chu Shih, PhD
• Affiliation: TaiwanJ Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

1. Has history of allergy to JKB-122 or related compounds

2. Has human immunodeficiency virus (HIV) or is hepatitis B positive

3. Is with a current diagnosis of cirrhosis, both compensated and uncompensated
Child-Pugh A, B or C

4. Has positive urine drug screen at Screening

5. 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)

6. Is being treated with any prescription narcotic drug (including transdermal delivery
systems)

7. Has a known or suspected central nervous system disorder that may predispose to
seizures or lower the seizure threshold

8. Has unstable and uncontrollable hypertension (>180/110 mmHg)

9. 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)

10. Requires concomitant use of or treatment with opioids or other excluded drugs such as
hepatotoxic medications

11. Has received other investigational agents within 30 days prior to the first screening
visit (Day -28)

12. Has a disease that would require chronic use of prescription corticosteroids

13. Has either autoimmune or genetic liver disease

14. May be chronically or latently infected with microbial agents other than HCV

15. Has impaired renal function

16. Has BMI> 30 or BMI <18

17. If female, pregnant or lactating



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C

Intervention(s)

Drug: JKB-122 15mg

Drug: JKB-122 35mg

Drug: JKB-122 5mg

Drug: Placebo

Primary Outcome(s)

ALT [Time Frame: baseline and 12 weeks]

Secondary Outcome(s)

Clinical laboratory tests (Includes hematology, coagulation, and serum chemistry.) [Time Frame: Screening, Day 1, 15, 29, 57, 85 and 30 days after EOS]

Pharmacokinetic analysis (plasma concentration of JKB-122) [Time Frame: Day 1, 29, 57, 78]

Secondary ID(s)

JKB122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors