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

• Status: Not yet recruiting
• Trial end date: 2025-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eiger BioPharmaceuticals
• Treatments: Interferons

Criteria

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 prior to Screening

• Quantifiable HDV RNA by RT-PCR test at Screening

• 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)

• 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 variceal bleeding, ascites or encephalopathy)

• Treatment with interferons (IFNs) or immunomodulators within 12 months of randomization or refractory to prior IFN treatment.