Hepatitis BPhase 4NCT04202536
Switching From Tenofovir Disoproxil Fumarate to Besifovir Dipivoxil Maleate
A Phase 4 study testing Besifovir Dipivoxil Maleate and Tenofovir disoproxil fumarate(TDF) in people with Hepatitis B and Besifovir Dipivoxil Maleate, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
A research study to observe the safety, efficacy and tolerability of switching from Tenofovir Disoproxil Fumarate to Besifovir dipivoxil maleate in patients with chronic hepatitis B Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis B, Besifovir Dipivoxil Maleate, Tenofovir Disoproxil Fumarate
- What is being tested?
- Besifovir Dipivoxil Maleate and Tenofovir disoproxil fumarate(TDF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2019to Oct 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years of age and older, Male or female patients
- Patients who show positive HBsAg or has a history of chronic hepatitis B for the last six months or more before screening
- Patients who have been on tenofovir disoproxil fumarate (TDF) monotherapy for more than 48 weeks and are taking TDF at the time of clinical screening
- At screening, had HBV DNA < 20 IU/mL
- Patients who were explained about the purpose, methods and effects of the clinical trial and then, signed a written consent form
Who cannot join
- Patients who have received interferon (including Pegylation formulation) to treat chronic hepatitis for more than 12 months.
- Patients who have taken Besifovir
- Patients who have experienced hepatitis B virus resistance to antiviral drugs
- Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient
- Patient has history of organ transplantation
- Patients who had received the following drugs for the last two months before screening (however, short-term use (less than consecutive 14 days) of these drugs and low-dose aspirin (100 mg, maximally, 300 mg/day) are allowed.)
Show all 31Show fewer
- Nephrotoxic drugs (e.g. Aminoglycosides, Amphotericin B, NSAIDs)
- Hepatotoxic drugs (e.g. Erythromycin, Ketoconazole, Rifampin, Fluconazole, Dapsone)
- Anticoagulant (e.g. Warfarin)
- Patients who are suspected by an investigator to have the level of immunity decreased among patients who had been administered with immunosuppressants within 12 months before screening
- Patients who had been administered with long-term general corticosteroids (more than consecutive 14 days) at a high dose (more than prednisolone 20 mg daily*) within three months before screening (In case of local corticosteroids, an investigator decides it.)
- It is equal to cortisone 125 mg, hydrocortisone 100 mg, prednisone 20 mg, methylprednisolone 16 mg, triamcinolone 16 mg, dexamethasone 3 mg, betamethasone 2.4 mg
- Patients who have a past medical history of clinical alcohol or drug abuse within a year before screening or now are abusers
- Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus
- Patients who have other hepatic diseases (hematochromatosis, Wilson's disease, alcoholic liver diseases, nonalcoholic steatohepatitis, α1-antitrypsin deficiency) except hepatitis B
- Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems
- Patients who showed Glomerular Filtration Rate (GFR) less than 50 mL/min by calculating Modification of Diet in Renal Disease (MDRD: 1.86 x phosphocreatine -1.154 x age -0.203 (x 0.742 for women)) during screening
- Patients who showed alpha-fetoprotein(AFP) more than 50 ng/mL during screening and are estimated to have hepatocellular carcinoma (HCC) through liver/abdomen CT scans
- At least one of the following laboratory values during screening
- Hemoglobin < 9.0 g/dL
- Absolute neutrophil count (ANC) < 1.0 x 10^9 /L (1000 /mm^3)
- Platelet count < 75 x 10^9 /L (100 x 10^3 /mm3)
- Serum creatinine > 1.5 mg/dL
- Serum amylase > 2 x upper limit normal (ULN) and Lipase > 2 x ULN
- Total Bilirubin > 2 x ULN
- Serum albumin < 28 g/L (2.8 g/dL)
- Pregnant women, lactating women, or patients who planned pregnancy during a trial period
- Patients who participate in other clinical trials or is supposed to do so during the study period
- Patients who have hypersensitivity to the clinical trial drug in this clinical trial
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Patients who are considered to be unacceptable in this study under the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Medical Center
Ansan, Kyounggi-do
Hyung Joon Yim, M.D., Ph.D.
Hyung Joon Yim, M.D., Ph.D.
About this study
Official title: A Randomized, Open-Label, Parallel, Multi-Center, Non-inferiority, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Switching to Besifovir Dipivoxil Maleate From Tenofovir Disoproxil Fumarate (TDF) in Chronic Hepatitis B Patients Who Pretreated With TDF
A research study to observe the safety, efficacy and tolerability of switching from Tenofovir Disoproxil Fumarate to Besifovir dipivoxil maleate in patients with chronic hepatitis B
- Being tested
- Besifovir Dipivoxil Maleate, Tenofovir disoproxil fumarate(TDF)
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Besifovir Dipivoxil MaleateDrug
Besifovir 150 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d. Other Name: Besifovir®
Tenofovir disoproxil fumarate(TDF)Drug
300 mg tablet administered orally once daily Other Name: VIREAD®
| Study group | Role | What they receive |
|---|---|---|
| TDF switch to Besifovir Dipivoxil Maleate | Experimental | Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Besifovir Dipivoxil Maleate 183mg daily Receives: Drug: Besifovir Dipivoxil Maleate |
| Maintaining on TDF | Active comparator | Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily Receives: Drug: Tenofovir disoproxil fumarate(TDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of subjects who maintained hepatitis B virus (HBV) DNA less than 20 IU/mL at the 48th week
Measured: at the 48th week
Secondary outcomes (1)
The rate of subjects who maintained HBV DNA less than 20 IU/mL at the 24th week
Measured: at the 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start29 May 2019
- Primary completionJun 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202536
- Sponsor's protocol ID
- ID-BVCL-403
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- 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 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel, Multi-Center, Non-inferiority, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Switching to Besifovir Dipivoxil Maleate From Tenofovir Disoproxil Fumarate (TDF) in Chronic Hepatitis B Patients Who Pretreated With TDF
- ClinicalTrials.gov ID
- NCT04202536
- Acronym / sponsor ID
- ID-BVCL-403
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 29 May 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 17 Dec 2019 (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.
A research study to observe the safety, efficacy and tolerability of switching from Tenofovir Disoproxil Fumarate to Besifovir dipivoxil maleate in patients with chronic hepatitis B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDF switch to Besifovir Dipivoxil Maleate | Experimental | Drug: Besifovir Dipivoxil MaleateTenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Besifovir Dipivoxil Maleate 183mg daily |
| Maintaining on TDF | Active comparator | Drug: Tenofovir disoproxil fumarate(TDF)Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20 years of age and older, Male or female patients
- Patients who show positive HBsAg or has a history of chronic hepatitis B for the last six months or more before screening
- Patients who have been on tenofovir disoproxil fumarate (TDF) monotherapy for more than 48 weeks and are taking TDF at the time of clinical screening
- At screening, had HBV DNA < 20 IU/mL
- Patients who were explained about the purpose, methods and effects of the clinical trial and then, signed a written consent form
Key exclusion criteria (31 listed)
- Patients who have received interferon (including Pegylation formulation) to treat chronic hepatitis for more than 12 months.
- Patients who have taken Besifovir
- Patients who have experienced hepatitis B virus resistance to antiviral drugs
- Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient
- Patient has history of organ transplantation
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 |
|---|---|---|
| Besifovir Dipivoxil MaleateBesifovir 150 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d. Other Name: Besifovir® | Drug | TDF switch to Besifovir Dipivoxil Maleate |
| Tenofovir disoproxil fumarate(TDF)300 mg tablet administered orally once daily Other Name: VIREAD® | Drug | Maintaining on TDF |
Primary outcome
The rate of subjects who maintained hepatitis B virus (HBV) DNA less than 20 IU/mL at the 48th week
Time frame: at the 48th week
1 secondary outcome
The rate of subjects who maintained HBV DNA less than 20 IU/mL at the 24th week
Time frame: at the 24th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- 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.
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 Besifovir Dipivoxil Maleate and Tenofovir disoproxil fumarate(TDF) in people with Hepatitis B and Besifovir Dipivoxil Maleate, run by IlDong Pharmaceutical Co Ltd 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 5 inclusion and 31 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 17 Dec 2019. 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 Yoan Park (82-2-526-3524, yapark@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of subjects who maintained hepatitis B virus (HBV) DNA less than 20 IU/mL at the 48th week (time frame: at the 48th week). 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 17 Dec 2019.