Peginterferon Lambda for Chronic Hepatitis D
(LIMT-2 Trial)
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for patients with chronic Hepatitis D (HDV) who have been on anti-HBV treatment and have low HBV DNA levels. They should have a certain level of liver enzyme ALT, stable liver function (Child-Turcotte-Pugh score ≤ 5), and no recent use or resistance to interferons.Inclusion Criteria
Exclusion Criteria
Timeline
Run-in
Participants receive 12 weeks of anti-HBV NUC therapy to ensure virologic control of HBV prior to randomization
Treatment
Participants receive Peginterferon Lambda 180 mcg once weekly for 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Peginterferon Lambda-1a
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eiger BioPharmaceuticals
Lead Sponsor