Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04202536
Other study ID # ID-BVCL-403
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 29, 2019
Est. completion date October 2021

Study information

Verified date December 2019
Source IlDong Pharmaceutical Co Ltd
Contact Yoan Park
Phone 82-2-526-3524
Email yapark@ildong.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Recruiting
Enrollment 152
Est. completion date October 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. 20 years of age and older, Male or female patients

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 been on tenofovir disoproxil fumarate (TDF) monotherapy for more than 48 weeks and are taking TDF at the time of clinical screening

4. At screening, had HBV DNA < 20 IU/mL

5. Patients who were explained about the purpose, methods and effects of the clinical trial and then, signed a written consent form

Exclusion Criteria:

1. Patients who have received interferon (including Pegylation formulation) to treat chronic hepatitis for more than 12 months.

2. Patients who have taken Besifovir

3. Patients who have experienced hepatitis B virus resistance to antiviral drugs

4. Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient

5. Patient has history of organ transplantation

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 12 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 have a past medical history of clinical alcohol or drug abuse within a year before screening or now are abusers

10. Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus

11. Patients who have other hepatic diseases (hematochromatosis, Wilson's disease, alcoholic liver diseases, nonalcoholic steatohepatitis, a1-antitrypsin deficiency) except hepatitis B

12. Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems

13. 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

14. 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

15. 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)

16. Pregnant women, lactating women, or patients who planned pregnancy during a trial period

17. Patients who participate in other clinical trials or is supposed to do so during the study period

18. Patients who have hypersensitivity to the clinical trial drug in this clinical trial

19. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

20. Patients who are considered to be unacceptable in this study under the opinion of the investigator

Study Design


Intervention

Drug:
Besifovir Dipivoxil Maleate
Besifovir 150 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d. Other Name: Besifovir®
Tenofovir disoproxil fumarate(TDF)
300 mg tablet administered orally once daily Other Name: VIREAD®

Locations

Country Name City State
Korea, Republic of Korea University Medical Center Ansan Kyounggi-do

Sponsors (1)

Lead Sponsor Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of subjects who maintained hepatitis B virus (HBV) DNA less than 20 IU/mL at the 48th week at the 48th week
Secondary The rate of subjects who maintained HBV DNA less than 20 IU/mL at the 24th week at the 24th week
See also
  Status Clinical Trial Phase
Completed NCT01182311 - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed NCT04971928 - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment Phase 1
Completed NCT03285620 - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants Phase 1
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT02153320 - Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers Phase 1
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Completed NCT03567382 - Arresting Vertical Transmission of Hepatitis B Virus Phase 4
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Not yet recruiting NCT03604016 - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Recruiting NCT03027258 - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome N/A
Terminated NCT02604199 - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection Phase 2
Completed NCT02540538 - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders Phase 1
Completed NCT02421666 - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV N/A
Completed NCT02169674 - Hepatitis B Booster Study in Adolescence Phase 4
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01368497 - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection Phase 3
Completed NCT01732354 - Study for Consolidation Period of Chronic Hepatitis B
Recruiting NCT01462981 - Cohort of Hepatitis B Research of Amsterdam N/A