CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni] +2 moredrug
Likely dose
Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03312023
NCT03312023Phase 2Completed
CompareCT.gov

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

University of Maryland, Baltimore·interventional·Posted Oct 17, 2017·Updated Sep 20, 2021

In Brief

A Phase 2 clinical trial evaluating Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni], Sofosbuvir 400 MG [Sovaldi], and 1 other intervention for Hepatitis B. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 17, 2017
Enrollment StartFeb 1, 2018
Primary CompletionAug 10, 2020
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.7 years ago

Interventions

Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]drug

1 pill once daily for 12 weeks for Group A

Sofosbuvir 400 MG [Sovaldi]drug

1 pill once daily for 12 weeks for Group C

Ledipasvir 90 MGdrug

1 pill once daily for 12 weeks for Group D