Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV
- Conditions
- Hepatitis Delta Virus
- Interventions
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
Fundeni Clinical Institute
🇷🇴Bucharest, Romania
Acibadem City Clinic Tokuda Hospital
🇧🇬Sofia, Bulgaria
Infectious diseases, AIDS and Clinical Immunology Research Center
🇬🇪Tbilisi, Georgia
Universitätsmedizin Mainz, I. Med. Klinik
🇩🇪Mainz, Germany
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Institutul de Cardiologie Chisinau
🇲🇩Chisinau, Moldova, Republic of
APHP, Hôpital Avicenne
🇫🇷Bobigny, France
CHU Grenoble-Alpes
🇫🇷Grenoble, France
LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic
🇬🇪Tbilisi, Georgia
ZIM 1, Gastroenterologie, University Hospital Frankfurt
🇩🇪Frankfurt, Germany
Ankara City Hospital
🇹🇷Ankara, Turkey
Asian Pacific Liver Center at Coalition of Inclusive Medicine
🇺🇸Los Angeles, California, United States
NYU Langone Health / NYU Grossman School of Medicine
🇺🇸New York, New York, United States
University Hospital Antwerp
🇧🇪Edegem, Antwerp, Belgium
CUB Hôpital Erasme
🇧🇪Brussels, Belgium
Icahn School of Medicine - Mount Sinai Medical Center
🇺🇸New York, New York, United States
CHU Brugmann
🇧🇪Brussels, Belgium
Hôpital Beaujon
🇫🇷Clichy, France
LTD Academician Nikoloz Kipshidze Central University Clinic
🇬🇪Tbilisi, Georgia
National Institute for Infectious Diseases "Matei Bals"
🇷🇴Bucharest, Romania
Dr. Victor Babes Foundation
🇷🇴Bucuresti, Romania
Koc University Hospital
🇹🇷Istanbul, Turkey
Hospital Universitario Fundación Alcorcón
🇪🇸Madrid, Spain
Dicle University, Medical Faculty
🇹🇷Diyarbakır, Turkey
Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine
🇹🇷Istanbul, Turkey
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
Stanford Medicine Outpatient Center
🇺🇸Redwood City, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Sutter Pacific Medical Foundation - California Pacific Medical Center
🇺🇸San Francisco, California, United States
Hopital Saint Eloi
🇫🇷Montpellier, Herault, France
Henri-Mondor Hospital
🇫🇷Creteil, France
CHU de Rouen
🇫🇷Rouen, France
Medizinische Hochschule Hannover
🇩🇪Hanover, Germany
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
The Liver Diseases Center, Sheba Medical Center
🇮🇱Ramat Gan, Tel Hashomer, Israel
Soroka University Medical Center
🇮🇱Beer-Sheba, Israel
Rambam Health Care Center
🇮🇱Haifa, Israel
Spitalul de Infectioase Galati Romania
🇷🇴Galati, Romania
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Ege University Medical Faculty
🇹🇷Bornova, Turkey
Medical Center "Nov Rehabilitatsionen Centre" EOOD
🇧🇬Stara Zagora, Bulgaria
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, Clermont-Ferrand Cedex, France
Emek Medical Center
🇮🇱Afula, Israel
Hadassah University Hospital - Ein Kerem
🇮🇱Jerusalem, Israel
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
CHU Toulouse
🇫🇷Toulouse, France
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
🇮🇹Foggia, Italy