NCT03312023

Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection

A Phase II Open-Label Study of Ledipasvir/Sofosbuvir for 12 Weeks in Subjects With Hepatitis B Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goals of therapy against chronic hepatitis B are to decrease the morbidity and mortality related to chronic HBV infection. Currently available antiviral therapy can suppress viral replication but only a small proportion attain functional cure, which is defined as HBV surface antigen-to-antibody seroconversion. Hepatitis B surface antigen (HBsAg) is a marker of persistent hepatitis B infection. It has been observed that patients who had both hepatitis B and hepatitis C, and who were treated for their hepatitis C with 12 weeks of ledipasvir/sofosbuvir for had a decline in HBsAg levels. This study hypothesizes that a similar decrease would be seen in mono-infected hepatitis B subjects over the course of 12 weeks treatment with ledipasvir/sofosbuvir.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]	1 pill once daily for 12 weeks for Group A
DRUG	Sofosbuvir 400 MG [Sovaldi]	1 pill once daily for 12 weeks for Group C
DRUG	Ledipasvir 90 MG	1 pill once daily for 12 weeks for Group D

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-08-10
• Completion: 2021-06-30
• First posted: 2017-10-17
• Last updated: 2021-09-20
• Results posted: 2021-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study