Hepatitis Delta Virus
Conditions
Keywords
HDV, Hepatitis D, Viral Hepatitis
Brief summary
The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA \< LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA \< LLOQ at the Week 12 visit in the no-treatment comparator group.
Detailed description
This is a randomized, open-label, parallel arm study that will allocate patients (2:1) with chronic HDV infection to one of two treatment groups: Peginterferon Lambda 180 mcg QW for 48 weeks with 24 weeks follow-up (Arm 1, n=100), or no treatment for 12 weeks followed by Peginterferon Lambda treatment for 48 weeks with 24 weeks of follow-up (Arm 2, n=50). All patients will receive concomitant therapy with a potent 2nd generation anti-HBV nucleos(t)ide analogue (NUC) throughout the study duration. Data collected during Peginterferon Lambda treatment in Arm 2 will not be included in the primary analysis. The primary purpose of Arm 2 is to provide benchmark data in a parallel reference group for the expected rate of HDV RNA suppression among patients with chronic HDV infection who receive 12 weeks of anti-HBV NUC therapy alone. Prior to randomization, all patients will enter a run-in phase with 12 weeks of anti-HBV NUC therapy, which will ensure virologic control of HBV (\< 100 IU/mL) prior to randomization and start of Peginterferon Lambda therapy.
Interventions
Immunomodulator
Sponsors
Eiger BioPharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Chronic HDV infection documented by a positive HDV antibody test or a positive HDV RNA by RT PCR test for at least 6 months at Screening Visit 2 * Quantifiable HDV RNA by RT-PCR test at Screening Visit 2 * Documented confirmed suppression of HBV DNA (\< 100 IU/mL) following at least 12 weeks of anti-HBV NUC treatment with ETV or a TNF-based NUC (TDF or TAF) at Screening Visit 2 * Serum ALT \> upper limit of normal (ULN) and \< 10 × ULN. * Patients categorized with Child-Turcotte-Pugh score of ≤ 5 with well compensated liver disease.
Exclusion criteria
* History or current evidence of decompensated liver disease (episodes of bleeding esophageal or gastric varices, ascites and/or encephalopathy) * Treatment with interferons (IFNs) or immunomodulators within 6 months before Screening Visit 2 or refractory to prior IFN treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Durable Virologic Response | 72 weeks | HDV RNA below the limit of quantitation at 24 weeks post-treatment |
Countries
Belgium, Bulgaria, France, Georgia, Germany, Israel, Italy, Moldova, Romania, Spain, Turkey (Türkiye), United States
Outcome results
None listed