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

Sponsor
Eiger BioPharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05070364
Collaborator
(none)
150
Enrollment
53
Locations
2
Arms
36.8
Anticipated Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Peginterferon Lambda-1a
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Dec 21, 2021
Anticipated Primary Completion Date :
Jun 15, 2024
Anticipated Study Completion Date :
Jan 15, 2025

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Durable Virologic Response [72 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asian Pacific Liver Center at Coalition of Inclusive Medicine Los Angeles California United States 90020
    2 University of Southern California Los Angeles California United States 90033
    3 Stanford Medicine Outpatient Center Redwood City California United States 94063
    4 California Pacific Medical Center San Francisco California United States 94115
    5 Rush University Medical Center Chicago Illinois United States 60612
    6 NYU Langone Health / NYU School of Medicine New York New York United States 10016
    7 Icahn School of Medicine - Mount Sinai Hospital New York New York United States 10029
    8 C.H.U. Brugmann Bruxelles Belgium 1020
    9 Cliniques Universitaires de Bruxelles Hôpital Erasme Bruxelles Belgium 1070
    10 University Hospital Antwerp Edegem Belgium B-2650
    11 University Hospital Ghent Ghent Belgium 9000
    12 Acibadem City Clinic Tokuda Hospital Ead Sofia Bulgaria 1407
    13 Medical Center "Nov Rehabilitatsionen Tsentar", EOOD Stara Zagora Bulgaria 6000
    14 APHP, Hôpital Avicenne Bobigny France
    15 Hôpital Beaujon Clichy France 92110
    16 Hopital Henri-Mondor Creteil France 9400
    17 Chu Toulouse Toulouse France
    18 ZIM 1, Gastroenterologie, University Hospital Frankfurt Frankfurt Germany 60590
    19 Medizinische Hochschule Hannover Hanover Germany 30625
    20 Universitätsmedizin Mainz, I. Med. Klinik Mainz Germany 55131
    21 The Liver Diseases Center, Sheba Medical Center Ramat Gan Tel Hashomer Israel 5262000
    22 Emek Medical Center Afula Israel 1834113
    23 Soroka University Medical Center Beer-Sheba Israel
    24 Rambam Health Care Center Haifa Israel 3109601
    25 Hadassah University Hospital - Ein Kerem Jerusalem Israel 91120
    26 Casa Sollievo della Sofferenza San Giovanni Rotondo Foggia Italy 71013
    27 Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia Foggia Italy
    28 Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Milan Italy 20122
    29 Azienda Ospedaliero Universitaria Pisana Pisa Italy 56124
    30 Institutul de Cardiologie Chisinau Chisinau Moldova, Republic of 2025
    31 Fundeni Clinical Institute Bucharest Romania
    32 National Institute for Infectious Diseases "Matei Bals" Bucharest Romania
    33 Dr. Victor Babes Foundation Bucuresti Romania 030303
    34 Spitalul Clinic de Boli Infectioase Constanta Constanta Romania 900709
    35 Spitalul de Infectioase Galati Romania Galati Romania
    36 State budgetary institution of health care "Specialized clinical infectious diseases hospital" of the Ministry of health of Krasnodar region Krasnodar Russian Federation
    37 Modern Medicine Clinic, LLC Moscow Russian Federation 121293
    38 H-Clinic, LLC Moscow Russian Federation 127083
    39 Center Tagetnoy Terapii, LLC Moscow Russian Federation
    40 Medical center "Healthy family" Novosibirsk Russian Federation 630099
    41 Hepatolog, LLC Samara Russian Federation 443043
    42 Stavropol State Medical University Stavropol Russian Federation 355017
    43 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    44 Hospital Universitario Fundación Alcorcón Madrid Spain
    45 Dicle University, Medical Faculty Diyarbakır Turkey 21280
    46 Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine Istanbul Turkey 34098
    47 Koc University Hospital Istanbul Turkey
    48 Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital" of Ivano-Frankivsk Regional Council Ivano-Frankivsk Oblast Ukraine 76000
    49 Sumy State University Clinic Sumy Oblast Ukraine 40000
    50 Medical Center of LLC "Harmoniya Krasy" Kyiv Ukraine 01135
    51 Medical Center 'Ok!Clinic+' of International Institute of Clinical Studies LLC Kyiv Ukraine 02091
    52 Ternopil University Hospital Ternopil Ukraine
    53 Communal Noncommercial Enterprise Vinnytsia City Clinical Hospital #l, Infectious Department, National Pirogov Memorial Medical University, Vinnytsya , Chair of Infectious Diseases with Course in Epidemiolog Vinnytsia Ukraine

    Sponsors and Collaborators

    • Eiger BioPharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eiger BioPharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05070364
    Other Study ID Numbers:
    • EIG-LMD-002
    First Posted:
    Oct 7, 2021
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eiger BioPharmaceuticals
    HDV
    Hepatitis D
    Viral Hepatitis
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis D
    Hepatitis
    Interferons

    Study Results

    No Results Posted as of Aug 23, 2022