Chronic Hepatitis BPhase 4NCT02523547
Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude
A Phase 4 study testing Cavir and Baraclude in people with Chronic Hepatitis B, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study. 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?
- Cavir and Baraclude
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Feb 2017
- Phase
- Phase 4
- 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
- Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with < HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening.
Who cannot join
- Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC)
- Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV)
- Patient had documented resistance mutations at any time before or at screening
- Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease.
- Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study.
- Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks.
Show all 9Show fewer
- Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) < 50ml/min, Total bilirubin > 3.0 mg/dl, Albumin < 2.7 g/dl, Prothrombin time > INR 2.3
- Patient is pregnant or breastfeeding or willing to be pregnant
- Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years
Trial locations and contacts
1 site in 1 country.
Hanmi Pharmaceutical contact
South Korea1 site, 1 recruiting
- Recruiting
15 Sites
Seoul
MoonHwa Park, MD, 8224109190, moonwha.park@hanmi.co.kr
About this study
Official title: PhaseIVstudy to Evaluate the Non-inferiority of Cavir®Tab. in Terms of Hepatitis B Virus(HBV)DNA Undetectability Comparing Baraclude® Tab. in Hepatitis B e Antigen(HBeAg)(+) Chronic Hepatitis B Patients Treated With Long-term Baraclude® Tab
Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.
Read the detailed description
The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.
- Conditions
- Chronic Hepatitis B
- Being tested
- Cavir, Baraclude
- Keywords
- entecavir
- 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.
CavirDrug
Also called entecavir
0.5mg/day
BaracludeDrug
Also called entecavir
0.5mg/day
| Study group | Role | What they receive |
|---|---|---|
| Cavir | Experimental | entecavir/0.5mg/day Receives: Drug: Cavir |
| Baraclude | Active comparator | entecavir/0.5mg/day Receives: Drug: Baraclude |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with maintenance of HBV DNA undetectability
analysis
Measured: 48weeks
Secondary outcomes (9)
The proportion of patients with HBeAg seroconversion
analysis
Measured: at week 12, 24, 36 and 48 of treatment
The proportion of patients with HBeAg seroclearance
analysis
Measured: at week 12, 24, 36 and 48 of treatment
The proportion with HBsAg seroclearance
analysis
Measured: at week 48 of treatment
The proportion with HBeAg seroconversion and HBsAb positive
analysis
Measured: at week 48 of treatment
Changes in serum HBV DNA levels
analysis
Measured: at week 48 of treatment
Changes in HBsAg titer
analysis
Measured: at week 48 of treatment
Changes in ALanine amino Transferase (ALT)
analysis
Measured: at week 48 of treatment
Proportion of patients with virologic breakthrough
virologic breakthrough is defined as the increase in serum HBV DNA (>60IU/ml) as determined by at least 2 consecutive measurements of at least 3 month apart, during continued treatment
Measured: at week 48 of treatment
Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)
questionnaire
Measured: at week 48 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (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 Hanmi Pharmaceutical Company LimitedThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523547
- Sponsor's protocol ID
- HM-CAV-401
- Status last verified
- Aug 2015
- First submitted
- 26 Jul 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseIVstudy to Evaluate the Non-inferiority of Cavir®Tab. in Terms of Hepatitis B Virus(HBV)DNA Undetectability Comparing Baraclude® Tab. in Hepatitis B e Antigen(HBeAg)(+) Chronic Hepatitis B Patients Treated With Long-term Baraclude® Tab
- ClinicalTrials.gov ID
- NCT02523547
- Acronym / sponsor ID
- HM-CAV-401
- Conditions
- Chronic Hepatitis B
- Keywords
- entecavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 14 Aug 2015 (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.
Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.
Detailed description
The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cavir | Experimental | Drug: Cavirentecavir/0.5mg/day |
| Baraclude | Active comparator | Drug: Baracludeentecavir/0.5mg/day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with < HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening.
Key exclusion criteria (9 listed)
- Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC)
- Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV)
- Patient had documented resistance mutations at any time before or at screening
- Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease.
- Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study.
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 |
|---|---|---|
| CavirAlso: entecavir0.5mg/day | Drug | Cavir |
| BaracludeAlso: entecavir0.5mg/day | Drug | Baraclude |
Primary outcome
The proportion of patients with maintenance of HBV DNA undetectability
Time frame: 48weeks
analysis
9 secondary outcomes
The proportion of patients with HBeAg seroconversion
Time frame: at week 12, 24, 36 and 48 of treatment
The proportion of patients with HBeAg seroclearance
Time frame: at week 12, 24, 36 and 48 of treatment
The proportion with HBsAg seroclearance
Time frame: at week 48 of treatment
The proportion with HBeAg seroconversion and HBsAb positive
Time frame: at week 48 of treatment
Changes in serum HBV DNA levels
Time frame: at week 48 of treatment
Changes in HBsAg titer
Time frame: at week 48 of treatment
Changes in ALanine amino Transferase (ALT)
Time frame: at week 48 of treatment
Proportion of patients with virologic breakthrough
Time frame: at week 48 of treatment
Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)
Time frame: at week 48 of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
Related trials for Chronic Hepatitis B
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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.
Hanmi Pharmaceutical contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cavir and Baraclude in people with Chronic Hepatitis B, run by Hanmi Pharmaceutical Company Limited at 1 site 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 1 inclusion and 9 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 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Hanmi Pharmaceutical, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with maintenance of HBV DNA undetectability (time frame: 48weeks). 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 14 Aug 2015.