drugset / Trial / NCT02792088
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
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2015-07
- Primary completion
- 2020-02
- Completion
- 2020-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Besifovir | Other / unclassified | 150 mg | Oral |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Background | L-carnitine | Other / unclassified | 660 mg | Oral |