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Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 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 Nucleos(t)Ide Therapy (D-LIVR)
 
Region Sponsors
California - Northern
Eiger Pharmecuticals
 
Acronym KP IRB No.
1413323
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with confirmed Hepatitis Delta Virus
 
Purpose
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.
 
Detailed 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.
 
Gender Age Limit
Male & Female
 
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
  • Baseline liver biopsy demonstrating evidence of chronic hepatitis
  • ECGs demonstrating no acute ischemia or clinically significant abnormality
  • Normal dilated retinal examination
 
Exclusion Criteria
  • 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
  • 5.Current evidence or history of ascites requiring diuretics or paracentesis, or hepatic encephalopathy
  • History of hepatocellular carcinoma
  • Please contact study team for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Anti-HIV Agents
  • Interferon alpha-2
  • Anti-Infective Agents
  • Interferon-alpha
  • Antineoplastic Agents
  • Interferons
  • Anti-Retroviral Agents
  • Liver Diseases
  • Antiviral Agents
  • Lonafarnib
  • Cytochrome P-450 CYP3A Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Cytochrome P-450 Enzyme Inhibitors
  • Peginterferon alfa-2a
  • Digestive System Diseases
  • Physiological Effects of Drugs
  • Enzyme Inhibitors
  • Protease Inhibitors
  • Hepatitis
  • Ritonavir
  • Hepatitis D
  • RNA Virus Infections
  • Hepatitis, Viral, Human
  • Virus Diseases
  • HIV Protease Inhibitors
  • Gastroenterology
  • Immunologic Factors
 
KP Clinical Facility
  • Sacramento Medical Center
 
Clinical Area
  • Gastroenterology


Principal Investigator:
Chhaya p Hasyagar, MD
Contact Information:
- Renee Cunanan, BS
-Sacramento Medical Center


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