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

NCT05070364 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: EIG-LMD-002
• Study Type: interventional
• Target: 150
• Locations: 12 countries
• Sites: 48

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.

Conditions

Hepatitis Delta Virus

Keywords

HDV; Hepatitis D; Viral Hepatitis

Outcome Measures

Primary Outcomes (1)

• Durable Virologic Response

  HDV RNA below the limit of quantitation at 24 weeks post-treatment

  72 weeks

Study Arms (2)

Peginterferon Lambda for 48 weeks

EXPERIMENTAL

Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up

Drug: Peginterferon Lambda-1a

No treatment for 12 weeks

NO INTERVENTION

No treatment for 12 weeks followed by Peginterferon Lambda 180 mcg once weekly for 48 weeks and 24 weeks follow-up

Interventions

Peginterferon Lambda-1a DRUG

Immunomodulator

Also known as: Lambda, Peginterferon Lambda, Pegylated Interferon Lambda

Peginterferon Lambda for 48 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eiger BioPharmaceuticals: lead

Study Sites (48)

Asian Pacific Liver Center at Coalition of Inclusive Medicine

Los Angeles, California, 90020, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Stanford Medicine Outpatient Center

Redwood City, California, 94063, United States

Location

Sutter Pacific Medical Foundation - California Pacific Medical Center

San Francisco, California, 94109, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NYU Langone Health / NYU Grossman School of Medicine

New York, New York, 10016, United States

Location

Icahn School of Medicine - Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

CHU Brugmann

Brussels, 1020, Belgium

Location

CUB Hôpital Erasme

Brussels, B-1070, Belgium

Location

Acibadem City Clinic Tokuda Hospital

Sofia, 1407, Bulgaria

Location

Medical Center "Nov Rehabilitatsionen Centre" EOOD

Stara Zagora, 6001, Bulgaria

Location

CHU Clermont-Ferrand

Clermont-Ferrand, Clermont-Ferrand Cedex, 63100, France

Location

Hopital Saint Eloi

Montpellier, Herault, 34000, France

Location

APHP, Hôpital Avicenne

Bobigny, 93000, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Henri-Mondor Hospital

Créteil, 94000, France

Location

CHU Grenoble-Alpes

Grenoble, 38043, France

Location

CHU de Rouen

Rouen, 76031, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic

Tbilisi, 0144, Georgia

Location

Infectious diseases, AIDS and Clinical Immunology Research Center

Tbilisi, 0160, Georgia

Location

LTD Academician Nikoloz Kipshidze Central University Clinic

Tbilisi, 0160, Georgia

Location

ZIM 1, Gastroenterologie, University Hospital Frankfurt

Frankfurt, 60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsmedizin Mainz, I. Med. Klinik

Mainz, 55131, Germany

Location

The Liver Diseases Center, Sheba Medical Center

Ramat Gan, Tel Hashomer, 5262000, Israel

Location

Emek Medical Center

Afula, 1834113, Israel

Location

Soroka University Medical Center

Beersheba, Israel

Location

Rambam Health Care Center

Haifa, 3109601, Israel

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 91120, Israel

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, Italy

Location

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Location

Institutul de Cardiologie Chisinau

Chisinau, 2025, Moldova

Location

Dr. Victor Babes Foundation

Bucharest, 030303, Romania

Location

Fundeni Clinical Institute

Bucharest, Romania

Location

National Institute for Infectious Diseases "Matei Bals"

Bucharest, Romania

Location

Spitalul de Infectioase Galati Romania

Galati, Romania

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Fundación Alcorcón

Madrid, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Location

Ege University Medical Faculty

Bornova, 35100, Turkey (Türkiye)

Location

Dicle University, Medical Faculty

Diyarbakır, 21280, Turkey (Türkiye)

Location

Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine

Istanbul, 34098, Turkey (Türkiye)

Location

Koc University Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hepatitis D

Interventions

peginterferon lambda-1a

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: December 21, 2021
• Primary Completion: June 15, 2024
• Study Completion: January 15, 2025
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (6); ES (3); BE (3); DE (3); FR (8); IT (3); US (7); MO (1); IL (5); RO (4); BU (2); GE (3)