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

Hepatitis Delta Virus Clinical Trial

— LIMT-2  

Official title:

Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients With Chronic Hepatitis Delta Virus (HDV) Infection (LIMT-2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05070364
• Other study ID #: EIG-LMD-002
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 21, 2021
• Est. completion date: January 15, 2025

Study information

• Verified date: August 2023
• Source: Eiger BioPharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: January 15, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis Delta Virus

Intervention

Drug:
• Peginterferon Lambda-1a
Immunomodulator

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels
Belgium	CUB Hôpital Erasme	Brussels
Belgium	University Hospital Antwerp	Edegem	Antwerp
Bulgaria	Acibadem City Clinic Tokuda Hospital	Sofia
Bulgaria	Medical Center "Nov Rehabilitatsionen Centre" EOOD	Stara Zagora
France	APHP, Hôpital Avicenne	Bobigny
France	CHU Clermont-Ferrand	Clermont-Ferrand	Clermont-Ferrand Cedex
France	Hôpital Beaujon	Clichy
France	Henri-Mondor Hospital	Creteil
France	CHU Grenoble-Alpes	Grenoble
France	Hopital Saint Eloi	Montpellier	Herault
France	CHU de Rouen	Rouen
France	CHU Toulouse	Toulouse
Georgia	Infectious diseases, AIDS and Clinical Immunology Research Center	Tbilisi
Georgia	LTD Academician Nikoloz Kipshidze Central University Clinic	Tbilisi
Georgia	LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic	Tbilisi
Germany	ZIM 1, Gastroenterologie, University Hospital Frankfurt	Frankfurt
Germany	Medizinische Hochschule Hannover	Hanover
Germany	Universitätsmedizin Mainz, I. Med. Klinik	Mainz
Israel	Emek Medical Center	Afula
Israel	Soroka University Medical Center	Beer-Sheba
Israel	Rambam Health Care Center	Haifa
Israel	Hadassah University Hospital - Ein Kerem	Jerusalem
Israel	The Liver Diseases Center, Sheba Medical Center	Ramat Gan	Tel Hashomer
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia	Foggia
Italy	Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico	Milan
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Moldova, Republic of	Institutul de Cardiologie Chisinau	Chisinau
Romania	Fundeni Clinical Institute	Bucharest
Romania	National Institute for Infectious Diseases "Matei Bals"	Bucharest
Romania	Dr. Victor Babes Foundation	Bucuresti
Romania	Spitalul de Infectioase Galati Romania	Galati
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Fundación Alcorcón	Madrid
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Turkey	Ankara City Hospital	Ankara
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Ege University Medical Faculty	Bornova
Turkey	Dicle University, Medical Faculty	Diyarbakir
Turkey	Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine	Istanbul
Turkey	Koc University Hospital	Istanbul
United States	Rush University Medical Center	Chicago	Illinois
United States	Asian Pacific Liver Center at Coalition of Inclusive Medicine	Los Angeles	California
United States	Keck Medical Center of USC	Los Angeles	California
United States	Icahn School of Medicine - Mount Sinai Medical Center	New York	New York
United States	NYU Langone Health / NYU Grossman School of Medicine	New York	New York
United States	Stanford Medicine Outpatient Center	Redwood City	California
United States	Sutter Pacific Medical Foundation - California Pacific Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Eiger BioPharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  France,  Georgia,  Germany,  Israel,  Italy,  Moldova, Republic of,  Romania,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durable Virologic Response	HDV RNA below the limit of quantitation at 24 weeks post-treatment	72 weeks