Clinical trial NCT05070364: Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hepatitis Delta Virus
Keywords: HDV
Hepatitis D
Viral Hepatitis
Lead sponsor: Eiger BioPharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-10-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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.

Primary outcomes:
measure: Durable Virologic Response
timeFrame: 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Asian Pacific Liver Center at Coalition of Inclusive Medicine
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center
state: California
city: San Francisco
country: United States
facility: Sutter Pacific Medical Foundation - California Pacific Medical Center
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: New York
country: United States
facility: NYU Langone Health / NYU Grossman School of Medicine
state: New York
city: New York
country: United States
facility: Icahn School of Medicine - Mount Sinai Medical Center
state: New York
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: CUB Hôpital Erasme
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Centre" EOOD
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
state: Clermont-Ferrand Cedex
city: Montpellier
country: France
facility: Hopital Saint Eloi
state: Herault
city: Bobigny
country: France
facility: APHP, Hôpital Avicenne
city: Clichy
country: France
facility: Hôpital Beaujon
city: Creteil
country: France
facility: Henri-Mondor Hospital
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
city: Rouen
country: France
facility: CHU de Rouen
city: Toulouse
country: France
facility: CHU Toulouse
city: Tbilisi
country: Georgia
facility: LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic
city: Tbilisi
country: Georgia
facility: Infectious diseases, AIDS and Clinical Immunology Research Center
city: Tbilisi
country: Georgia
facility: LTD Academician Nikoloz Kipshidze Central University Clinic
city: Frankfurt
country: Germany
facility: ZIM 1, Gastroenterologie, University Hospital Frankfurt
city: Hanover
country: Germany
facility: Medizinische Hochschule Hannover
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, I. Med. Klinik
city: Ramat Gan
country: Israel
facility: The Liver Diseases Center, Sheba Medical Center
state: Tel Hashomer
city: Afula
country: Israel
facility: Emek Medical Center
city: Beer-Sheba
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
city: Milan
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Chisinau
country: Moldova, Republic of
facility: Institutul de Cardiologie Chisinau
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: National Institute for Infectious Diseases "Matei Bals"
city: Bucuresti
country: Romania
facility: Dr. Victor Babes Foundation
city: Galati
country: Romania
facility: Spitalul de Infectioase Galati Romania
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Bornova
country: Turkey
facility: Ege University Medical Faculty
city: Diyarbakır
country: Turkey
facility: Dicle University, Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine
city: Istanbul
country: Turkey
facility: Koc University Hospital
Study officials:
References: