Phase 2
N=15
Titrating-Dose of Lonafarnib in Combination With Ritonavir
Chronic Delta Hepatitis
Bottom Line
View on ClinicalTrials.gov: NCT02527707 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Jun 2023
Primary outcome: Primary: Change From Baseline to Week 24 in Mean Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) Titer — -1.62 log IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lonafarnib (Drug); Ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eiger BioPharmaceuticals
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 in Mean Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) Titer |
-1.62 | — |
| SECONDARY Number of Patients With 1 Log Reduction From Baseline by Timepoint |
7; 6; 10; 11; 10; 12 | — |
Summary
A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically infected with hepatitis delta virus (HDV)
Eligibility Criteria
Key Inclusion Criteria
- Male or female, 18 to 65 years of age, inclusive
- Chronic HDV infection documented by a positive HDV antibody (Ab) test of at least 6 months duration and detectable HDV ribonucleic acid (RNA) by quantitative polymerase chain reaction (qPCR) at study entry
- Liver biopsy demonstrating evidence of chronic hepatitis
- Willingness to practice appropriate contraception
Key Exclusion Criteria
- Previous use of lonafarnib
- Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
- Active jaundice defined by total bilirubin level >2.0 mg/dL and known not to have Gilbert's disease
- Decompensated liver disease or cirrhosis, history of bleeding esophageal varices, ascites, or hepatic encephalopathy
- Serum creatinine concentration ≥1.5 times upper limit of normal (ULN)
- Evidence of another form of viral hepatitis (not including hepatitis B virus or HCV) or another form of liver disease
- Evidence of hepatocellular carcinoma
- Use of alfa interferon, either interferon alfa-2a or interferon alfa-2b, or peginterferon alfa-2a within 2 months before the start of screening
- Concomitant use of any of the following:
- Medications or foods that are known moderate or strong inducers or inhibitors of CYP3A4 or CYP2C19
- Drugs known to prolong the PR interval or QT interval of the electrocardiogram
- Receipt of systemic immunosuppressive therapy within the 3 months before start of screening
- Statins, due to inhibition of mevalonate synthesis, which reduces protein prenylation
- Medications contraindicated in the prescribing information for ritonavir
Data sourced from ClinicalTrials.gov (NCT02527707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.