Chronic Hepatitis BPhase 3NCT02805738
Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet
A Phase 3 study testing CKD-390 and viread in people with Chronic Hepatitis B, run by Chong Kun Dang Pharmaceutical at 20 sites in South Korea.
Trial summary
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- CKD-390 and viread
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 20 sitesSouth Korea
- Study dates
- Apr 2016to Mar 2018
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female older than 19 years at the time of screening
- Patients who have chronic hepatitis B disease are taken Viried for 6 months
- Patients who show HBV DNA undetected(less than 20 IU/mL)
- Patients who show positive HBsAg
- Patients who show positive HBeAg or negative HBeAg
- Patients who fully understand the clinical trials after in-depth explanation, decided to join the clinical trials by their will and signed inform consent
Who cannot join
- Patients who are not taken any anti-viral agents except Viread Tab
- Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
- Patients who have seroperitoneum, icterus, hepatic encephalopathy, variceal hemorrhage or Patients with following value at screening
- total bilirubin > Upper normal limit x 1.5
- prothrombin time(INR) > Upper normal limit x 1.5
- platelets < 75,000/ul
Show all 19Show fewer
- serum albumin < 3.0g/dl
- Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 50ng/mL
- Patients who show Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation
- Patients with disease like heart failure, renal failure, pancreatitis that investigators consider ineligible for this study
- Patients who have other hepatic diseases like hematochromatosis, Wilson's disease, alcoholic cirrhosis, autoimmune hepatic diseases, α-1 antitrypsin deficit syndrome
- Patients with genetic disease like Galactose intolerance, lapplactase deficiency, Glucose-galactose malabsorption
- History of malignant tumor within 5 years
- Patients who take any other investigational product within 30 days
- Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial
- Pregnant, breast-feeding and childbearing age who don't use adequate contraception
- Patients who receive an organ transplant or bone marrow transplant or are going to received surgury
- History of allergic reaction to the investigational product
- Patients that investigators consider ineligible for this study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
South Korea20 sites, 10 recruiting
- Not yet recruiting
Korea University Ansan Hospital
Ansan, Gyeonggi-do
Hyengjun Lim, MD, 82-31-412-6565, gudwns21@medimail.co.kr
- Not yet recruiting
Bundang Cha Medical Center
Bundang, Gyeonggi-do
Sunggue Hwang, MD, 82-31-780-5213, sghwang@cha.ac.kr
- Active, not recruiting
Busan National University Hospital
Busan
- Active, not recruiting
Keimyung University Dongsan Medical Center
Daegu
- Not yet recruiting
Yeungnam University Medical Center
Daegu
Heonju Lee, MD, 82-53-620-3834, heonjulee@yu.ac.kr
- Not yet recruiting
Chungnam National University Hospital
Daejeon
Byengseok Lee, MD, 82-2-2019-3314, leeks519@yuhs.ac
- Recruiting
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do
Joohyun Sohn, MD, 82-31-560-2225, sonjh@hanyang.ac.kr
- Recruiting
Inje University Ilsan Paik Hospital
Ilsan, Gyeonggi-do
June Sung Lee, MD, 82-31-910-7823, jsleemd@paik.ac.kr
- Active, not recruiting
Gachon University of Medicine and Science Gil Medical Center
Incheon, Gyeonggi-do
- Not yet recruiting
Jeju National University Hospital
Jeju City
Byungcher Song, MD, 82-64-717-1643, drsong@jejunu.ac.kr
- Active, not recruiting
Chungang University Hospital
Seoul
- Active, not recruiting
Hanyang University Hospital
Seoul
- Not yet recruiting
Kangnam Severance Hospital
Seoul
Kwan Sik Lee, MD, 82-2-2019-2332, leeks519@yuhs.ac
- Not yet recruiting
Korea University Guro Hosptial
Seoul
Jihoon Kim, MD, 82-2-2626-3011, kjhhepar@naver.com
- Active, not recruiting
Samsung Medical Center
Seoul
- Active, not recruiting
Seoul Asan Medical Center
Seoul
- Active, not recruiting
Seoul National University Hospital
Seoul
- Active, not recruiting
Seoul Saint Mary's Hospital
Seoul
- Not yet recruiting
Severance Hospital
Seoul
Do Young Kim, MD, 82-2-2228-0525, dyk1025@yuhs.ac
- Active, not recruiting
Ajou University Hospital
Suwon, Gyeonggi-do
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet and Viread® Tablet in Chronic Hepatitis B Patients
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet
Read the detailed description
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet and Viread® tablet in Chronic hepatitis B Patients Subjects will receive either a single oral dose of the test formulation(CKD-390) or a oral dose of the reference formulation(viread).
- Conditions
- Chronic Hepatitis B
- Being tested
- CKD-390, viread
- Keywords
- Chronic Hepatitis B, tenofovir, CKD-390
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-390Drug
Also called Tenofovir disoproxil aspartate 308.04mg
CKD-390 1 Tablet (48 weeks)
vireadDrug
Also called Tenofovir disoproxil fumarate 300mg
viread1 Tablet (24 weeks), CKD-390 1 Tablet (from 24 weeks to 48 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | once a time per a day, CKD-390 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks Receives: Drug: CKD-390 |
| Active comparator Group | Active comparator | once a time per a day, Viread 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks Receives: Drug: viread |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Measured: 24weeks after drug administration
Secondary outcomes (8)
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Measured: 12, 36, 48 weeks after drug administration
The Difference between the baseline and at the 12, 24, 36, 48 week of HBV DNA level
Measured: 12, 24, 36, 48 weeks after drug administration
The rate of subjects who had normal ALT result
Measured: 12, 24, 36, 48weeks after drug administration
The rate of subjects who showed HBeAg loss
Measured: 24, 48 weeks after drug administration
The rate of subjects who showed HBeAg seroconversion
Measured: 24, 48 weeks after drug administration
The rate of subjects who showed HBsAg loss
Measured: 24, 48 weeks after drug administration
The rate of subjects who showed HBsAg seroconversion
Measured: 24, 48 weeks after drug administration
The rate of subjects who showed Virologic breakthrough
Measured: 12, 24, 36, 48 weeks after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kwan Sik lee, MD, Principal investigator, Kangnam severance hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805738
- Sponsor's protocol ID
- 163HBV15036
- Status last verified
- Apr 2016
- First submitted
- 16 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet and Viread® Tablet in Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT02805738
- Acronym / sponsor ID
- 163HBV15036
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B, tenofovir, CKD-390
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 20 Jun 2016 (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.
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet
Detailed description
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet and Viread® tablet in Chronic hepatitis B Patients Subjects will receive either a single oral dose of the test formulation(CKD-390) or a oral dose of the reference formulation(viread).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: CKD-390once a time per a day, CKD-390 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks |
| Active comparator Group | Active comparator | Drug: vireadonce a time per a day, Viread 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female older than 19 years at the time of screening
- Patients who have chronic hepatitis B disease are taken Viried for 6 months
- Patients who show HBV DNA undetected(less than 20 IU/mL)
- Patients who show positive HBsAg
- Patients who show positive HBeAg or negative HBeAg
Key exclusion criteria (19 listed)
- Patients who are not taken any anti-viral agents except Viread Tab
- Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
- Patients who have seroperitoneum, icterus, hepatic encephalopathy, variceal hemorrhage or Patients with following value at screening
- Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 50ng/mL
- Patients who show Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation
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 |
|---|---|---|
| CKD-390Also: Tenofovir disoproxil aspartate 308.04mgCKD-390 1 Tablet (48 weeks) | Drug | Experimental Group |
| vireadAlso: Tenofovir disoproxil fumarate 300mgviread1 Tablet (24 weeks), CKD-390 1 Tablet (from 24 weeks to 48 weeks) | Drug | Active comparator Group |
Primary outcome
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Time frame: 24weeks after drug administration
8 secondary outcomes
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Time frame: 12, 36, 48 weeks after drug administration
The Difference between the baseline and at the 12, 24, 36, 48 week of HBV DNA level
Time frame: 12, 24, 36, 48 weeks after drug administration
The rate of subjects who had normal ALT result
Time frame: 12, 24, 36, 48weeks after drug administration
The rate of subjects who showed HBeAg loss
Time frame: 24, 48 weeks after drug administration
The rate of subjects who showed HBeAg seroconversion
Time frame: 24, 48 weeks after drug administration
The rate of subjects who showed HBsAg loss
Time frame: 24, 48 weeks after drug administration
The rate of subjects who showed HBsAg seroconversion
Time frame: 24, 48 weeks after drug administration
The rate of subjects who showed Virologic breakthrough
Time frame: 12, 24, 36, 48 weeks after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Kwan Sik lee, MD principal investigator
Kangnam severance hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CKD-390 and viread in people with Chronic Hepatitis B, run by Chong Kun Dang Pharmaceutical at 20 sites in South Korea.
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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) (time frame: 24weeks after drug administration). 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 Jun 2016.