Hepatitis BPhase 4NCT03604016
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
A Phase 4 study testing Besifovir dipivoxil, L-carnitine and Tenofovir Alafenamide in people with Hepatitis B, run by IlDong Pharmaceutical Co Ltd.
Trial summary
Pilot study to assess the antiviral activity and safety of Besifovir dipivoxil 150mg and L-carnitine 660mg compared to Tenofovir Alafenamide 25mg in chronic hepatitis B patients with Nonalcoholic fatty liver Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Besifovir dipivoxil, L-carnitine and Tenofovir Alafenamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2018to 30 Jul 2020
- 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
- Chronic hepatitis B patients with Nonalcoholic fatty liver
- Patients who use oral anti-diabetic drug or drugs for hyperlipemia without any change in drug dosage within 2 month before screening visit
- Patients who have been explained about the trial and agreed to the consent
- Patients who agree with the approved method of contraception during the clinical trial
Who cannot join
- Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus
- Patients who has a history of liver transplantation or Child-Pugh score >=8
- Alpha-fetoprotein (AFP) > 50 ng/mL or Hepatocellular Carcinoma (HCC) patients
- Patients who have taken Besifovir or Vemlidy
- Among the patients treated with immunosuppressive drug within 6 months before screening, suspected case of the declined immunity in the opinion of the investigator
- Chronic alcoholism (Significant alcohol consumption: male > 210 g/week, female> 140 g/week)
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- Patients who take drugs that can cause hepatic steatosis
- Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient
- Patients with uncontrolled diabetes mellitus (HbA1c > 9%) or using insulin
- Patients who participate in other clinical trials or is supposed to do so during the study period
- Pregnant or breast-feeding women or women who have plan to be pregnant.
- Patients with a history of hypersensitivity to the test drug or the components of the test drug
- Patients with moderate or severe renal impairment
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- History within the past one years or presence of drug abuse or alcoholism.
- Patient has serious disease judged by investigator such as heart failure, renal failure, and pancreatitis
- Patient has liver diseases except chronic hepatitis B (i.e. hematochromatosis, alcoholic liver disease, nonalcoholic fatty liver disease, alpha-1 antitrypsin deficiency etc.)
- Patient has history of organ transplantation
- Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems
- Patients who are considered to be unacceptable in this study under the opinion of the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study to Assess the Antiviral Activity and Safety of Besifovir Dipivoxil 150mg and L-carnitine 660mg Compared to Tenofovir Alafenamide 25mg in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
Pilot study to assess the antiviral activity and safety of Besifovir dipivoxil 150mg and L-carnitine 660mg compared to Tenofovir Alafenamide 25mg in chronic hepatitis B patients with Nonalcoholic fatty liver
- Conditions
- Hepatitis B
- Being tested
- Besifovir dipivoxil, L-carnitine, Tenofovir Alafenamide
- 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 dipivoxilDrug
Besifovir dipivoxil 150 mg
L-carnitineDrug
Besifovir dipivoxil 150 mg
Tenofovir AlafenamideDrug
Tenofovir Alafenamide 25mg
| Study group | Role | What they receive |
|---|---|---|
| Besifovir dipivoxil+L-carnitine | Experimental | Besifovir dipivoxil 150 mg and L-carnitine 330 mg Receives: Drug: Besifovir dipivoxil; Drug: L-carnitine |
| Tenofovir Alafenamide | Active comparator | Tenofovir Alafenamide 25mg Receives: Drug: Tenofovir Alafenamide |
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 116 copies/mL (20 IU/mL)) at the 48 week
Measured: at the 48th week
Secondary outcomes (1)
The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 24 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 posted27 Jul 2018
- Study start23 Sep 2018 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (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
- 76 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
- NCT03604016
- Sponsor's protocol ID
- ID-BVCL-401
- Status last verified
- Jun 2018
- First submitted
- 19 Jul 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Antiviral Activity and Safety of Besifovir Dipivoxil 150mg and L-carnitine 660mg Compared to Tenofovir Alafenamide 25mg in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
- ClinicalTrials.gov ID
- NCT03604016
- Acronym / sponsor ID
- ID-BVCL-401
- Conditions
- Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2018 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 27 Jul 2018 (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.
Pilot study to assess the antiviral activity and safety of Besifovir dipivoxil 150mg and L-carnitine 660mg compared to Tenofovir Alafenamide 25mg in chronic hepatitis B patients with Nonalcoholic fatty liver
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Besifovir dipivoxil+L-carnitine | Experimental | Drug: Besifovir dipivoxil, Drug: L-carnitineBesifovir dipivoxil 150 mg and L-carnitine 330 mg |
| Tenofovir Alafenamide | Active comparator | Drug: Tenofovir AlafenamideTenofovir Alafenamide 25mg |
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
- Chronic hepatitis B patients with Nonalcoholic fatty liver
- Patients who use oral anti-diabetic drug or drugs for hyperlipemia without any change in drug dosage within 2 month before screening visit
- Patients who have been explained about the trial and agreed to the consent
- Patients who agree with the approved method of contraception during the clinical trial
Key exclusion criteria (20 listed)
- Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus
- Patients who has a history of liver transplantation or Child-Pugh score >=8
- Alpha-fetoprotein (AFP) > 50 ng/mL or Hepatocellular Carcinoma (HCC) patients
- Patients who have taken Besifovir or Vemlidy
- Among the patients treated with immunosuppressive drug within 6 months before screening, suspected case of the declined immunity in the opinion of the investigator
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 dipivoxilBesifovir dipivoxil 150 mg | Drug | Besifovir dipivoxil+L-carnitine |
| L-carnitineBesifovir dipivoxil 150 mg | Drug | Besifovir dipivoxil+L-carnitine |
| Tenofovir AlafenamideTenofovir Alafenamide 25mg | Drug | Tenofovir Alafenamide |
Primary outcome
The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 48 week
Time frame: at the 48th week
1 secondary outcome
The rate of subjects who showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 24 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 23 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Besifovir dipivoxil, L-carnitine and Tenofovir Alafenamide in people with Hepatitis B, run by IlDong Pharmaceutical Co Ltd.
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 20 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Minju Hong (82105263644, mjhong@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 showed HBV DNA undetected (less than 116 copies/mL (20 IU/mL)) at the 48 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 23 Aug 2018.