Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV

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.

Timeline

Start

2021-12-21

Primary completion

2024-06-15

Completion

2025-01-15

Publications

• Lampertico P, Anolli MP, Roulot D, Wedemeyer H. Antiviral therapy for chronic hepatitis delta: new insights from clinical trials and real-life studies. Gut. 2025 Apr 7;74(5):853-862. doi: 10.1136/gutjnl-2024-332597.

Drugs

Indications