Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eiger BioPharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Lonafarnib
  • Drug: Ritonavir
  • Drug: PEG IFN-alfa-2a
  • Drug: Placebo Lonafarnib
  • Drug: Placebo Ritonavir

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   1. 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.

   2. 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.

   3. Serum ALT > 1.3 x upper limit of the normal range (ULN) and < 10 x ULN.

   4. Baseline liver biopsy demonstrating evidence of chronic hepatitis.

   5. ECGs demonstrating no acute ischemia or clinically significant abnormality.

   6. Normal dilated retinal examination.

Exclusion Criteria:

General Exclusions

   1. Previous use of LNF within 12 months.

   2. Current or previous history of decompensated liver disease.

   3. Co-infected with human immunodeficiency virus or hepatitis C virus (HCV) by detectable
   HIV RNA and HCV RNA, respectively.

   4. Evidence of significant portal hypertension.

   5. Current evidence or history of ascites requiring diuretics or paracentesis, or hepatic
   encephalopathy.

   6. History of hepatocellular carcinoma.

   7. Patients with any of the following:

      - Current eating disorder

      - Evidence of alcohol substance use disorder.

      - Drug abuse within the previous 6 months before screening.

   8. 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.

   9. Other significant medical condition that may require intervention during the study.

10. Any condition that may impact proper absorption.

11. Therapy with an immunomodulatory agent, IFN-α (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.

12. Use of heparin or warfarin.

13. Systemic antibiotics, antifungals, or antivirals for treatment of active infection
   other than HBV.

14. Receipt of systemic immunosuppressive therapy.

15. History or evidence for any intolerance or hypersensitivity to LNF, RTV, PEG
   IFN-alfa-2a, tenofovir or entecavir.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Angela Fuller
650-721-4288
Not Recruiting