Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV
NCT ID: NCT05070364
Last Updated: 2023-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2021-12-21
2025-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peginterferon Lambda for 48 weeks
Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up
Peginterferon Lambda-1a
Immunomodulator
No treatment for 12 weeks
No treatment for 12 weeks followed by Peginterferon Lambda 180 mcg once weekly for 48 weeks and 24 weeks follow-up
No interventions assigned to this group
Interventions
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Peginterferon Lambda-1a
Immunomodulator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Treatment with interferons (IFNs) or immunomodulators within 6 months before Screening Visit 2 or refractory to prior IFN treatment.
18 Years
70 Years
ALL
No
Sponsors
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Eiger BioPharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Acibadem City Clinic Tokuda Hospital
Sofia, , Bulgaria
Medical Center "Nov Rehabilitatsionen Centre" EOOD
Stara Zagora, , Bulgaria
CHU Clermont-Ferrand
Clermont-Ferrand, Clermont-Ferrand Cedex, France
Hopital Saint Eloi
Montpellier, Herault, France
APHP, Hôpital Avicenne
Bobigny, , France
Hôpital Beaujon
Clichy, , France
Henri-Mondor Hospital
Créteil, , France
CHU Grenoble-Alpes
Grenoble, , France
CHU de Rouen
Rouen, , France
CHU Toulouse
Toulouse, , France
LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic
Tbilisi, , Georgia
Infectious diseases, AIDS and Clinical Immunology Research Center
Tbilisi, , Georgia
LTD Academician Nikoloz Kipshidze Central University Clinic
Tbilisi, , Georgia
ZIM 1, Gastroenterologie, University Hospital Frankfurt
Frankfurt, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsmedizin Mainz, I. Med. Klinik
Mainz, , Germany
The Liver Diseases Center, Sheba Medical Center
Ramat Gan, Tel Hashomer, Israel
Emek Medical Center
Afula, , Israel
Soroka University Medical Center
Beersheba, , Israel
Rambam Health Care Center
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, , Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Institutul de Cardiologie Chisinau
Chisinau, , Moldova
Dr. Victor Babes Foundation
Bucharest, , Romania
Fundeni Clinical Institute
Bucharest, , Romania
National Institute for Infectious Diseases "Matei Bals"
Bucharest, , Romania
Spitalul de Infectioase Galati Romania
Galati, , Romania
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Fundación Alcorcón
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Ege University Medical Faculty
Bornova, , Turkey (Türkiye)
Dicle University, Medical Faculty
Diyarbakır, , Turkey (Türkiye)
Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine
Istanbul, , Turkey (Türkiye)
Koc University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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EIG-LMD-002
Identifier Type: -
Identifier Source: org_study_id
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