Chronic Hepatitis CPhase 2JKB122NCT02293941
Liver Test Study of Using JKB-122 in Hepatitis C Virus (HCV)-Positive Patients Nonresponsive to Prior Interferon Based Therapies
A Phase 2 study testing JKB-122 5mg, JKB-122 15mg and JKB-122 35mg in people with Chronic Hepatitis C, run by TaiwanJ Pharmaceuticals Co., Ltd at 14 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- JKB-122 5mg, JKB-122 15mg and JKB-122 35mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 14 sitesTaiwan
- Study dates
- May 2014to 30 Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Taiwan14 sites
Changhua Christian Hospital
Changhua, 500
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Chiayi City, 622
Chang Gung Memorial Hospital, Chiayi
Chiayi City
Chia-Yi Christian Hospital
Chiayi City
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City
Chang Gung Memorial Hospital, Keelung
Keelung
Chi Mei Medical Center - Liouying Branch
Tainan, 736
Chi Mei Hospital, YongKang Branch
Tainan
Cathay General Hospital
Taipei, 280
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
China Medical University Beigang Hospital
Yuanlin, 651
National Taiwan University Hospital, Yun-Lin Branch
Yuanlin
About this study
Official 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
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
- Being tested
- JKB-122 5mg, JKB-122 15mg, JKB-122 35mg, Placebo
- Keywords
- liver inflammation
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JKB-122 5mgDrug
Participants were randomized to receive JKB-122 5mg for 12 weeks
JKB-122 15mgDrug
Participants were randomized to receive JKB-122 15mg for 12 weeks
JKB-122 35mgDrug
Participants were randomized to receive JKB-122 35mg for 12 weeks
PlaceboDrug
Participants were randomized to receive comparable placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| JKB-122 5mg | Experimental | 5mg, oral, once daily Receives: Drug: JKB-122 5mg |
| JKB-122 15 mg | Experimental | 15mg, oral, once daily Receives: Drug: JKB-122 15mg |
| JKB-122 35 mg | Experimental | 35mg, oral, once daily Receives: Drug: JKB-122 35mg |
| placebo | Placebo comparator | comparable capsule, oral, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALT
To assess changes in ALT in HCV-infected subjects given daily doses of JKB-122
Measured: baseline and 12 weeks
Secondary outcomes (2)
Pharmacokinetic analysis (plasma concentration of JKB-122)
plasma concentration of JKB-122 will be measured for exploration of exposure/response relationships in all subjects of each dose group at Stage 1.
Measured: Day 1, 29, 57, 78
Clinical laboratory tests (Includes hematology, coagulation, and serum chemistry.)
Includes hematology, coagulation, and serum chemistry.
Measured: Screening, Day 1, 15, 29, 57, 85 and 30 days after EOS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startMay 2014
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Why it stopped: Completed stage I without pursuing stage II
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiwanJ Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying-Chu Shih, PhD, Study director, TaiwanJ Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293941
- Sponsor's protocol ID
- JKB122
- Acronym
- JKB122
- Status last verified
- Jul 2020
- First submitted
- 13 Nov 2014
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02293941
- Acronym / sponsor ID
- JKB122 / JKB122
- Conditions
- Chronic Hepatitis C
- Keywords
- liver inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Completed stage I without pursuing stage II
- Enrolment
- 54 participants (actual)
- Lead sponsor
- TaiwanJ Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JKB-122 5mg | Experimental | Drug: JKB-122 5mg5mg, oral, once daily |
| JKB-122 15 mg | Experimental | Drug: JKB-122 15mg15mg, oral, once daily |
| JKB-122 35 mg | Experimental | Drug: JKB-122 35mg35mg, oral, once daily |
| placebo | Placebo comparator | Drug: Placebocomparable capsule, oral, once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JKB-122 5mgParticipants were randomized to receive JKB-122 5mg for 12 weeks | Drug | JKB-122 5mg |
| JKB-122 15mgParticipants were randomized to receive JKB-122 15mg for 12 weeks | Drug | JKB-122 15 mg |
| JKB-122 35mgParticipants were randomized to receive JKB-122 35mg for 12 weeks | Drug | JKB-122 35 mg |
| PlaceboParticipants were randomized to receive comparable placebo for 12 weeks | Drug | placebo |
Primary outcome
ALT
Time frame: baseline and 12 weeks
To assess changes in ALT in HCV-infected subjects given daily doses of JKB-122
2 secondary outcomes
Pharmacokinetic analysis (plasma concentration of JKB-122)
Time frame: Day 1, 29, 57, 78
Clinical laboratory tests (Includes hematology, coagulation, and serum chemistry.)
Time frame: Screening, Day 1, 15, 29, 57, 85 and 30 days after EOS
Results and safety
The study was stopped early (reason given: Completed stage I without pursuing stage II). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Chu Shih, PhD study director
TaiwanJ Pharmaceuticals
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JKB-122 5mg, JKB-122 15mg and JKB-122 35mg in people with Chronic Hepatitis C, run by TaiwanJ Pharmaceuticals Co., Ltd at 14 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Completed stage I without pursuing stage II). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALT (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.