Chronic Hepatitis BPhase 4NCT04539652
Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients
A Phase 4 study testing Experimental in people with Chronic Hepatitis B, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks 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?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Sep 2018to 22 Jun 2021
- 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
- Inclusion Criteria:
- Patients who show positive HBsAg
- Patients who show positive or negative HBeAg
- Exclusion Criteria:
- Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)
- Patients with a history of allergic reaction to Tenofovir
- Patients who are unable to participate in clinical trials based on investigator's decision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Single-Arm, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients in Treatment of Oral Antiviral Therapy for Hepatitis B Virus
This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks
- Conditions
- Chronic Hepatitis B
- Being tested
- Experimental
- 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.
ExperimentalDrug
Experimental group are treated with TenofoBell®
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of subjects with HBV DNA less than 20 IU/mL
Measured: change after 48 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start20 Sep 2018
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539652
- Sponsor's protocol ID
- 285HBV18018
- Status last verified
- Jul 2021
- First submitted
- 1 Sep 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients in Treatment of Oral Antiviral Therapy for Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT04539652
- Acronym / sponsor ID
- 285HBV18018
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 7 Sep 2020 (actual)
- 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.
This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Experimental |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ExperimentalExperimental group are treated with TenofoBell® | Drug | Experimental group |
Primary outcome
Rate of subjects with HBV DNA less than 20 IU/mL
Time frame: change after 48 weeks compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Experimental in people with Chronic Hepatitis B, run by Chong Kun Dang Pharmaceutical 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?
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: finished, as of the sponsor's last update on 28 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of subjects with HBV DNA less than 20 IU/mL (time frame: change after 48 weeks compared to baseline). 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 28 Jul 2021.