Chronic Hepatitis B
Conditions
Keywords
HBV
Brief summary
To prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic hepatitis B patients
Detailed description
* Screening Period Subject registration is conducted with confirming selection and exclusion criteria after a written consent form is obtained within 42 days before clinical trial drug administration. * 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.
Interventions
DRUGBesifovir 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.
DRUGTenofovir 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.
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who show positive HBsAg or has a history of chronic hepatitis B for the last six months or more before screening * Patients who showed positive HBsAg during screening * Have developed nucleoside analogue resistant HB * Had no received nucleotide analogue
Exclusion criteria
1. Treatment with pegylated interferons within 6 months 2. Prior exposure to BSV 3. Mutations conferring resistance to ADV 4. Serum HBV DNA levels \< 69 IU/mL 5. Coinfection with hepatitis C, hepatitis D or human immunodeficiency viruses 6. ALT levels ≥ 10 x ULN 7. Evidence of decompensated liver disease (Total bilirubin \> 2 x ULN, prothrombin time \> 6 sec prolonged or INR \>1.5, serum albumin \<2.8 g/dL, uncontrolled ascites, overt hepatic encephalopathy, or Child-Pugh score ≥8) 8. Certain laboratory abnormalities (Hemoglobin \< 9.0 g/dL, absolute neutrophil count (ANC) \< 1 x 109/L (1000/mm3), platelet count \< 75 x 109/L (75 x 103/mm3), serum Creatinine \> 1.5 mg/dL, or serum amylase \> 2 x ULN and Lipase \> 2 x ULN) 9. Decreased estimated glomerular filtration rates \< 50 mL/min 10. Presence of hepatocellular carcinoma or elevated alpha feto-protein \> 50 ng/mL 11. Current use of aspirin or nonsteroidal anti-inflammatory drugs within 2 month 12. Current use of immunosuppressive agents within 6 months 13. Current use of high dose corticosteroids (prednisolone \> 20 mg/day or equivalent dose over 14 days) with 3 months 14. History of malignancy within 5 years 15. Subjects who are participating in other clinical trials 16. Pregnant or lactating women 17. Hypersensitivity to the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week | at the 48th week |
Secondary
| Measure | Time frame |
|---|---|
| The rate of subjects who showed ALT normalized at the 48th week | at the 48th week |
Countries
South Korea
Outcome results
None listed