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

Phase 3

Active, not recruiting

• Conditions: Hepatitis Delta Virus
• Interventions: Drug: Peginterferon Lambda-1a

• Registration Number: NCT05070364
• Lead Sponsor: Eiger BioPharmaceuticals

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.

Study Timeline

• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-07
• Study Start: 2021-12-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25
• Primary Completion: 2024-06-15
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peginterferon Lambda for 48 weeks	Peginterferon Lambda-1a	Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up

Primary Outcome Measures

Name	Time	Method
Durable Virologic Response	72 weeks	HDV RNA below the limit of quantitation at 24 weeks post-treatment

Trial Locations

Locations (48)

Asian Pacific Liver Center at Coalition of Inclusive Medicine; 🇺🇸 Los Angeles, California, United States

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States

Stanford Medicine Outpatient Center; 🇺🇸 Redwood City, California, United States

Sutter Pacific Medical Foundation - California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

NYU Langone Health / NYU Grossman School of Medicine; 🇺🇸 New York, New York, United States

Icahn School of Medicine - Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium

CHU Brugmann; 🇧🇪 Brussels, Belgium

CUB Hôpital Erasme; 🇧🇪 Brussels, Belgium

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