Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a

  • STATUS
    Recruiting
  • End date
    Nov 1, 2021
  • participants needed
    400
  • sponsor
    Eiger BioPharmaceuticals
Updated on 24 March 2021

Summary

Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. 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 IU/mL reduction from baseline.

Description

This partially double-blind, randomized study will employ a matrix (factorial) design to evaluate the efficacy and safety of LNF 50 mg/RTV 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) nucleos(t)ide maintenance therapy.

Approximately 400 patients will be randomized with an allocation ratio of 7:5:2:2 All patients will receive/maintain background anti-HBV nucleos(t)ide 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.

Details
Condition Hepatitis D Virus
Treatment Ritonavir, lonafarnib, PEG IFN-alfa-2a, Placebo Lonafarnib, Placebo Ritonavir
Clinical Study IdentifierNCT03719313
SponsorEiger BioPharmaceuticals
Last Modified on24 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Chronic HDV infection for at least 6 months in duration, documented by a positive HDV antibody test and HDV RNA 500 IU/mL
Note: All genotypes of HDV permitted
\. Demonstrable suppression of HBV DNA following at least 12 weeks of anti-
HBV nucleos(t)ide treatment with entecavir or tenofovir prior to initiating
therapy
\. Serum ALT > 1.3 x upper limit of the normal range (ULN) and < 10 x ULN
\. Baseline liver biopsy demonstrating evidence of chronic hepatitis
\. ECGs demonstrating no acute ischemia or clinically significant
abnormality
\. Normal dilated retinal examination

Exclusion Criteria

General Exclusions
Previous use of LNF within 12 months
Current or previous history of decompensated liver disease
Co-infected with human immunodeficiency virus or hepatitis C virus (HCV) by detectable HIV RNA and HCV RNA, respectively
Evidence of significant portal hypertension
Current evidence or history of ascites requiring diuretics or paracentesis, or hepatic encephalopathy
History of hepatocellular carcinoma
Patients with any of the following
Current eating disorder
Evidence of alcohol substance use disorder
Drug abuse within the previous 6 months before screening
Prior history or current evidence of any of the following
Immunologically mediated disease
Retinal disorder or clinically relevant ophthalmic disorder
Any malignancy within 5 years before screening
Cardiomyopathy or significant ischemic cardiac or cerebrovascular disease
Chronic pulmonary disease
Pancreatitis or colitis
Severe or uncontrolled psychiatric disorder
Other significant medical condition that may require intervention during the study
Any condition that may impact proper absorption
Therapy with an immunomodulatory agent, IFN- (eg, IFN alfa-2a or IFN-alfa-2b, or pegylated IFN-alfa-2a or alfa 2b), cytotoxic agent, or chronic systemic corticosteroids within 12 months of screening
Use of heparin or warfarin
Systemic antibiotics, antifungals, or antivirals for treatment of active infection other than HBV
Receipt of systemic immunosuppressive therapy
History or evidence for any intolerance or hypersensitivity to LNF, RTV, PEG IFN-alfa-2a, tenofovir or entecavir
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