Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03719313
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2018-10-18
Brief Title:
Study of the Efficacy and Safety of Lonafarnib Ritonavir With and Without Pegylated Interferon -Alfa-2a
Sponsor:
Eiger BioPharmaceuticals
Organization:
Eiger BioPharmaceuticals
Study Overview
Official Title:
A Phase 3 Matrix Design Partially Double-Blind Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib100 mg Ritonavir BID With and Without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared With PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected With Hepatitis Delta Virus Being Maintained on Anti-HBV NucleostIde Therapy D-LIVR
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
D-LIVR
Brief Summary:
Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study 1 LNFRTVPEG IFN-alfa-2a and 2 LNFRTV Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase ALT normalization For each LNF-containing regimen a composite endpoint of EOT 48 weeks virologic response and ALT normalization will be used Virologic response will be defined as a 2 log10 IUmL reduction from baseline
Detailed Description:
This partially double-blind randomized study will employ a matrix factorial design to evaluate the efficacy and safety of LNF 50 mgRTV 100 mg twice per day BID with and without PEG IFN-alfa-2a 180 mcg once-weekly QW for 48 weeks compared to no treatment placebo LNF and placebo RTV in patients chronically infected with hepatitis delta virus HDV and receiving anti-HBV hepatitis B virus nucleostide maintenance therapy
Approximately 400 patients will be randomized with an allocation ratio of 7522 All patients will receivemaintain background anti-HBV nucleostide therapy with entecavir or tenofovir for at least 12 weeks prior to initiating study therapy
All patients who complete 48 weeks of treatment will have a liver biopsy for histology assessment at EOT and will be followed for an additional 24 weeks off study treatment
Approximately 400 patients will be randomized with an allocation ratio of 7522 All patients will receivemaintain background anti-HBV nucleostide therapy with entecavir or tenofovir for at least 12 weeks prior to initiating study therapy
All patients who complete 48 weeks of treatment will have a liver biopsy for histology assessment at EOT and will be followed for an additional 24 weeks off study treatment
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?:
None
Is an FDA AA801 Violation?:
None