Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
197 participants
INTERVENTIONAL
2013-10-31
2023-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside Analogues
NCT02792088
Switching From Tenofovir Disoproxil Fumarate to Besifovir Dipivoxil Maleate
NCT04202536
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
NCT03604016
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
NCT02979613
Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection
NCT03903796
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Wash-out Period Subjects who had been treated with antiviral agents within 12 weeks should complete a 4-week wash-out period from the stage of stopping antiviral agent treatment before a baseline visit and subjects who have no experience of antiviral agent treatment start a baseline visit without a wash-out period.
* Baseline Subjects who visit on the date of starting clinical trial drug administration are randomized to a test group or a control group at a ratio of 1:1. Double blindness is applied for both groups.
* Treatment period Subjects are orally administered with a clinical trial drug q.ds.i.d. for 48 weeks and visit at the 0, 4th, 12th, 24th, 36th, and 48th week for an HBV DNA test, laboratory tests, a physical test, vital signs, and adverse events.
* Follow-up period Subjects are provided with appropriate treatment after completing the 48-week trial or dropping out. Subjects visit once at the 60th week for follow-up of adverse events, such as acute deterioration of hepatitis B, and HBV DNA test results. If any treatment is not conducted after 48-week administration, subjects visit at intervals of four weeks until a follow-up visit (60th week) and the same tests with the 24th week visit (Visit 5) are conducted. However, subjects who participate in a 48-week separate extended trial conducted after 48-week administration in this clinical trial do not have a follow-up period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
besifovir 150mg
Besifovir 150 mg q.d. + Placebo of Tenofovir Disoproxil Fumarate 300 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
besifovir 150mg
Besifovir 150 mg q.d. + Placebo of Tenofovir Disoproxil Fumarate 300 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
Tenofovir 300mg
Placebo of Besifovir 150 mg q.d. + Tenofovir Disoproxil Fumarate 300 mg q.d. + Placebo of L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
tenofovir 300mg
Placebo of Besifovir 150 mg q.d. + Tenofovir Disoproxil Fumarate 300 mg q.d. + Placebo of L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
besifovir 150mg
Besifovir 150 mg q.d. + Placebo of Tenofovir Disoproxil Fumarate 300 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
tenofovir 300mg
Placebo of Besifovir 150 mg q.d. + Tenofovir Disoproxil Fumarate 300 mg q.d. + Placebo of L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients who show positive HBsAg or has a history of chronic hepatitis B for the last six months or more before screening
3. Patients who have not received interferon (including Pegylation formulation) to treat chronic hepatitis and antiviral agents for more than 12 weeks.
4. Patients who showed positive HBsAg during screening
5. Patients who showed HBV DNA measured by COBAS TaqManTM HBV Test more than 1x105 copies/mL (17,241 IU/mL) in case of positive HBeAg during screening, or who showed HBV DNA measured by COBAS TaqManTM HBV Test more than 1x104 copies/mL (1,724 IU/mL) in case of negative HBeAg
6. Patients who showed ALT more than 1.2 times, or less than 10 times of the upper limit in the normal range during screening
7. Patients who were explained about the purpose, methods and effects of the clinical trial and then, signed a written consent form.
8. Male and female patients of childbearing age who can use double contraception acknowledged\* during a trial period \* Double contraception acknowledged means combination of barrier contraception (condom, diaphragm, etc.) and other contraception (sterilization operation, intrauterine contraceptive device, oral contraceptive drug, other hormone delivery system, contraceptive cream, jelly or foam, etc.).
Exclusion Criteria
2. Patients with a uncompensated liver disease who have at least one of the following values or signs during screening
* Total bilirubin \> 2 x ULN
* Prothrombin time delayed more than three seconds compared to the normal value
* Serum Albumin \< 30 g/L (3 g/dL)
* A medical history of ascites, jaundice, hemorrhage by varix, hepatic encephalopathy, or other signs of liver function loss
3. At least one of the following laboratory values during screening
* Hemoglobin \< 9.0 g/dL
* Absolute neutrophil count (ANC) \< 1.5 x 109 /L (1500 /mm3)
* Platelet count \< 100 x 109 /L (100 x 103 /mm3)
* Serum creatinine \> 1.5 mg/dL
* Serum amylase \> 2 x ULN and Lipase \> 2 x ULN
4. Patients who showed GFR less than 50 mL/min by calculating MDRD (Modification of Diet in Renal Disease: 1.86 x PCr -1.154 x AGE -0.203 (x 0.742 for women)) during screening
5. 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
6. 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.)
* Nephrotoxic drugs (e.g. Aminoglycosides, Amphotericin B, NSAIDs)
* Hepatotoxic drugs (e.g. Erythromycin, Ketoconazole, Rifampin, Fluconazole, Dapsone)
* Anticoagulant (e.g. Warfarin)
7. Patients who are suspected by an investigator to have the level of immunity decreased among patients who had been administered with immunosuppressants within six months before screening
8. 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.
9. Patients who were diagnosed as a malignant tumor within five years before screening or have a relapse of a malignant tumor (In case of a benign tumor, if an investigator decides that it does not affect the progress of the clinical trial during a trial period, the patients can be registered.)
10. Patients who are scheduled to participate in other clinical trial after registered in this clinical trial, or had been participated in other clinical trial within three months before registered in this clinical trial
11. Pregnant women, lactating women, or patients who planned pregnancy during a trial period
12. Patients who have hypersensitivity to the clinical trial drug in this clinical trial
13. Patients who have a past medical history of clinical alcohol or drug abuse within a year before screening or now are abusers
14. Patients who have a severe disease, such as liver diseases, heart failure, renal failure, and pancreatitis, decided by an investigator to have an effect on this clinical trial
15. Patients who have other hepatic diseases (hematochromatosis, Wilson's disease, alcoholic liver diseases, nonalcoholic steatohepatitis, α1-antitrypsin deficiency) except hepatitis B
16. Patients who received an organ transplant
17. Persons who are possible to decline daily function due to a mental disease or patients who are not able to understand the purpose and methods of this clinical trial
18. Patients who are decided by an investigator as unsuitable for conducting this clinical trial
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IlDong Pharmaceutical Co Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kwan Sik Lee, M.d., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Kangnam Severance Hospital, Yonsei University, Seoul, Korea
Young Oh Kweon, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Hospital, Seoul, Korea
Hyung Joon Yim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Medical Center, Ansan, Kyunggi-do, Korea
Soon Ho Um, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Medical Center, Seoul, Korea
Won Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Boramae medical Center, Seoul, Korea
Sung Jae Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Inje University Busan Paik Hospital, Pusan, Korea
Yoon Jun Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital, Seoul, Korea
Yoon Jun Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea
Young-Suk Lim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center, Seoul, Korea
JinMo Yang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea, Seoul St. Vincent's Hospital, Seoul, Korea
Jang, Jae Young, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Soonchunhyang University Hospital, Seoul, Korea
Jae-Youn Cheong, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ajou University Medical Center, Suwon, Kyunggi-do, Korea
Neung Hwa Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ulsan University Hospital, Ulsan, Korea
Moon Young Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wonju Sevrerance Christian Hospital, Wonju, Kangwon-do, Korea
Jin-Woo Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital, Incheon, Inchen, Korea
Dong Joon Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hallym University Medical Center, ChunCheon, Kangwon-do, Korea
Byung Seok Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chungnam National University Hospital
Joo Hyun Sohn, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hanyang University Guri Hospital, Guri, Kyunggi-do, Korea
Kwang-Hyub Han, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital of Yonsei University, Seoul, Korea
Hong Soo Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Soonchunhyang University Hospital, Choenan, Chungchoengnam-do, Korea
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Soonchunhyang University Hospital
Cheonan, Chungchoengnam-do, South Korea
Hallym University Medical Center
Chuncheon, Gangwon-do, South Korea
Wonju Sevrerance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea
Korea University Medical Center
Ansan, Kyounggi-do, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Inha University Hospital
Incheon, , South Korea
Inje University Busan Paik Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Korea University Medical Center
Seoul, , South Korea
Seoul National University Boramae medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital of Yonsei University
Seoul, , South Korea
Soonchunhyang University Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Vincent's Hospital
Seoul, , South Korea
Ulsan University Hospital,
Ulsan, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yim HJ, Kang SH, Jung YK, Ahn SH, Kim W, Yang JM, Jang JY, Kweon YO, Cho YK, Kim YJ, Hong GY, Kim DJ, Sohn JH, Lee JW, Park SJ, Yim SY, Park JK, Um SH. Reduced Risk of Hepatocellular Carcinoma in Patients with Chronic Hepatitis B Receiving Long-Term Besifovir Therapy. Cancers (Basel). 2024 Feb 22;16(5):887. doi: 10.3390/cancers16050887.
Song DS, Kim W, Ahn SH, Yim HJ, Jang JY, Kweon YO, Cho YK, Kim YJ, Hong GY, Kim DJ, Jung YK, Sohn JH, Lee JW, Park SJ, Lee BS, Kim JH, Kim HS, Yoon SK, Kim MY, Lee KS, Lim YS, Lee WS, Yang JM, Kim KH, Han KH, Um SH. Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial. Clin Mol Hepatol. 2021 Apr;27(2):346-359. doi: 10.3350/cmh.2020.0307. Epub 2021 Jan 25.
Yim HJ, Kim W, Ahn SH, Yang JM, Jang JY, Kweon YO, Cho YK, Kim YJ, Hong GY, Kim DJ, Jung YK, Um SH, Sohn JH, Lee JW, Park SJ, Lee BS, Kim JH, Kim HS, Yoon SK, Kim MY, Lee KS, Lim YS, Lee WS, Han KH. Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial. Am J Gastroenterol. 2020 Aug;115(8):1217-1225. doi: 10.14309/ajg.0000000000000605.
Ahn SH, Kim W, Jung YK, Yang JM, Jang JY, Kweon YO, Cho YK, Kim YJ, Hong GY, Kim DJ, Um SH, Sohn JH, Lee JW, Park SJ, Lee BS, Kim JH, Kim HS, Yoon SK, Kim MY, Yim HJ, Lee KS, Lim YS, Lee WS, Park NH, Jin SY, Kim KH, Choi W, Han KH. Efficacy and Safety of Besifovir Dipivoxil Maleate Compared With Tenofovir Disoproxil Fumarate in Treatment of Chronic Hepatitis B Virus Infection. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1850-1859.e4. doi: 10.1016/j.cgh.2018.11.001. Epub 2018 Nov 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ID_BVCL011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.