Overview

Titrating-Dose of Lonafarnib in Combination With Ritonavir

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
Summary
A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of titrating-dose lonafarnib in combination with ritonavir in patients chronically infected with hepatitis delta virus
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eiger BioPharmaceuticals
Collaborator:
Hannover Medical School
Treatments:
Lonafarnib
Ritonavir
Criteria
Key Inclusion Criteria:

1. Male or female, 18 to 65 years of age, inclusive

2. Chronic HDV infection documented by a positive HDV antibody (Ab) test of at least 6
months duration and detectable HDV RNA by qPCR at study entry

3. Liver biopsy demonstrating evidence of chronic hepatitis

4. Willingness to practice appropriate contraception

Key Exclusion Criteria:

1. Previous use of lonafarnib

2. Co-infected with HIV or HCV

3. Active jaundice defined by total bilirubin level >2.0 mg/dL and known not to have
Gilbert's disease

4. Decompensated liver disease or cirrhosis, history of bleeding esophageal varices,
ascites, or hepatic encephalopathy

5. Serum creatinine concentration ≥1.5 times upper limit of normal (ULN)

6. Evidence of another form of viral hepatitis or another form of liver disease

7. Evidence of hepatocellular carcinoma

8. Use of alpha interferon, either interferon alfa-2a or interferon alfa-2b, or pegylated
interferon alfa-2a within 2 months before the start of screening

9. Concomitant use of any of the following:

1. Medications or foods that are known moderate or strong inducers or inhibitors of
CYP3A4 or CYP2C19

2. Drugs known to prolong the PR or QT interval

3. Receipt of systemic immunosuppressive therapy within the 3 months before start of
screening

4. Statins, due to inhibition of mevalonate synthesis, which reduces protein
prenylation

5. Medications contraindicated in the prescribing information for ritonavir