Phase 2
N=55
Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2)
Chronic Hepatitis D Infection
Bottom Line
View on ClinicalTrials.gov: NCT02430194 ↗Enrolled (actual)
55
Serious AEs
14.5%
Results posted
Feb 2023
Primary outcome: Primary: ≥2 log10 Decline of HDV RNA From Baseline at End of Treatment (EOT) — 1; 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lonafarnib (Drug); ritonavir (Drug); Pegylated interferon-alfa-2a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eiger BioPharmaceuticals
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ≥2 log10 Decline of HDV RNA From Baseline at End of Treatment (EOT) |
1; 0; 1; 0; 1; 1 | — |
| SECONDARY < LLOQ in HDV RNA at End of Treatment (EOT) |
0; 1; 1; 0; 1; 0 | — |
| SECONDARY ALT Normalization at End of Treatment |
3; 1; 1; 2; 0; 2 | — |
Summary
An Open-label, Dose-ranging Study to Evaluate the Safety and Efficacy of Lonafarnib with Ritonavir Boosting +/- Peginterferon alfa-2a in Patients Chronically Infected with Delta Hepatitis (HDV) (LOWR-2).
Eligibility Criteria
Inclusion Criteria
- Males or females, 18 to 65 years of age who are diagnosed with HDV by PCR
- Chronic hepatitis D infection, genotype 1, documented by a positive anti-HDV Ab test at least of 6 months duration and detectable HDV RNA by PCR within 3 months to study entry
- Liver biopsy within the last two years (biopsy can be done at the Screening Visit)
- Positive viral load of >100, 000 copies/mL as measured by quantitative PCR
- Electrocardiogram (ECG) shows no acute ischemia or clinically significant abnormality and a QT/QTc interval 2.0 excluding Gilbert's disease
- INR ≥ 1.5
- Eating disorder or alcohol abuse within the past 2 years, excessive alcohol intake (> 20 g per day for females (1.5 standard alcohol drinks) or > 30 g per day for males (2.0 standard alcohol drinks) (a standard drink contains 14 g of alcohol: 12 oz of beer, 5 oz of wine or 1.5 oz of spirits) (1.0 fluid oz (US) = 29.57 mL)
- Drug abuse within the last six months with the exception of cannabinoids and their derivatives
- Patients with absolute neutrophil count (ANC) 6, decompensated liver disease or any other form of non-viral hepatitis
- immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) requiring more than intermittent nonsteroidal anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids (inhaled asthma medications are allowed)
- any malignancy within 3 years except for basal cell skin cancer
- significant or unstable cardiac disease (e.g., angina, congestive heart failure, uncontrolled hypertension, history of arrhythmia)
- chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment
- severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization 2
- Patients with a body mass index > 30 kg/m^2
- Concomitant drugs known to prolong the QT interval
Data sourced from ClinicalTrials.gov (NCT02430194). 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.