Ignite Creation Date:
2024-05-06 @ 10:39 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03312023
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2017-09-29
Brief Title:
LedipasvirSofosbuvir for Hepatitis B Virus Infection
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase II Open-Label Study of LedipasvirSofosbuvir for 12 Weeks in Subjects With Hepatitis B Virus Infection
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APOSTLE
Brief 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 ledipasvirsofosbuvir 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 ledipasvirsofosbuvir
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 ledipasvirsofosbuvir 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 ledipasvirsofosbuvir
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None