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

• Status: Unknown status
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IlDong Pharmaceutical Co Ltd
• Treatments: Antiviral Agents; Tenofovir

Criteria

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:

• Was co-infected with hepatitis C of hepatitis D virus or Human Immunodeficiency Virus

• Had confirmation of adefovir drug resistant mutation

• At screening, had alpha-fetoprotein (AFP) value > 20 ng/mL and a follow-up ultrasonography performed prior to baseline showed findings indicative of HCC