Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV (LIMT-2)

August 23, 2023 updated by: Eiger BioPharmaceuticals

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann
      • Brussels, Belgium, B-1070
        • CUB Hôpital Erasme
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • University hospital Antwerp
  • Bulgaria
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Hospital
      • Stara Zagora, Bulgaria, 6001
        • Medical Center "Nov Rehabilitatsionen Centre" EOOD
  • France
      • Bobigny, France, 93000
        • APHP, Hôpital Avicenne
      • Clichy, France, 92110
        • Hopital Beaujon
      • Creteil, France, 94000
        • Henri-Mondor Hospital
      • Grenoble, France, 38043
        • CHU Grenoble-Alpes
      • Rouen, France, 76031
        • CHU de Rouen
      • Toulouse, France, 31059
        • CHU Toulouse
    • Clermont-Ferrand Cedex
      • Clermont-Ferrand, Clermont-Ferrand Cedex, France, 63100
        • CHU Clermont-Ferrand
    • Herault
      • Montpellier, Herault, France, 34000
        • Hopital Saint Eloi
  • Georgia
      • Tbilisi, Georgia, 0160
        • Infectious diseases, AIDS and Clinical Immunology Research Center
      • Tbilisi, Georgia, 0160
        • LTD Academician Nikoloz Kipshidze Central University Clinic
      • Tbilisi, Georgia, 0144
        • LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic
  • Germany
      • Frankfurt, Germany, 60590
        • ZIM 1, Gastroenterologie, University Hospital Frankfurt
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz, I. Med. Klinik
  • Israel
      • Afula, Israel, 1834113
        • Emek Medical Center
      • Beer-Sheba, Israel
        • Soroka University Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Center
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital - Ein Kerem
    • Tel Hashomer
      • Ramat Gan, Tel Hashomer, Israel, 5262000
        • The Liver Diseases Center, Sheba Medical Center
  • Italy
      • Foggia, Italy
        • Azienda Ospedaliero Universitaria Ospedali Riuniti Di Foggia
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Pisa, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2025
        • Institutul de Cardiologie Chisinau
  • Romania
      • Bucharest, Romania
        • Fundeni Clinical Institute
      • Bucharest, Romania
        • National Institute for Infectious Diseases "Matei Bals"
      • Bucuresti, Romania, 030303
        • Dr. Victor Babes Foundation
      • Galati, Romania
        • Spitalul de Infectioase Galati Romania
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain
        • Hospital Universitario Fundacion Alcorcon
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
  • Turkey
      • Ankara, Turkey
        • Ankara City Hospital
      • Ankara, Turkey
        • Hacettepe University Medical Faculty
      • Bornova, Turkey, 35100
        • Ege University Medical Faculty
      • Diyarbakır, Turkey, 21280
        • Dicle University, Medical Faculty
      • Istanbul, Turkey
        • Koc University Hospital
      • Istanbul, Turkey, 34098
        • Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
      • Los Angeles, California, United States, 90020
        • Asian Pacific Liver Center at Coalition of Inclusive Medicine
      • Redwood City, California, United States, 94063
        • Stanford Medicine Outpatient Center
      • San Francisco, California, United States, 94109
        • Sutter Pacific Medical Foundation - California Pacific Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health / NYU Grossman School of Medicine
      • New York, New York, United States, 10029
        • Icahn School of Medicine - Mount Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peginterferon Lambda for 48 weeks
Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up
Drug: Peginterferon Lambda-1a
Immunomodulator
Other Names:
  • Lambda
  • Peginterferon Lambda
  • Pegylated Interferon Lambda
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durable Virologic Response
Time Frame: 72 weeks
HDV RNA below the limit of quantitation at 24 weeks post-treatment
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eiger BioPharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2021

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 7, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIG-LMD-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis Delta Virus

Clinical Trials on Peginterferon Lambda-1a

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe