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

Primary Purpose

Hepatitis Delta Virus

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Peginterferon Lambda-1a
Sponsored by
Eiger BioPharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis Delta Virus focused on measuring HDV, Hepatitis D, Viral Hepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asian Pacific Liver Center at Coalition of Inclusive Medicine
  • Keck Medical Center of USC
  • Stanford Medicine Outpatient Center
  • Sutter Pacific Medical Foundation - California Pacific Medical Center
  • Rush University Medical Center
  • NYU Langone Health / NYU Grossman School of Medicine
  • Icahn School of Medicine - Mount Sinai Medical Center
  • University Hospital Antwerp
  • CHU Brugmann
  • CUB Hôpital Erasme
  • Acibadem City Clinic Tokuda Hospital
  • Medical Center "Nov Rehabilitatsionen Centre" EOOD
  • CHU Clermont-Ferrand
  • Hopital Saint Eloi
  • APHP, Hôpital Avicenne
  • Hôpital Beaujon
  • Henri-Mondor Hospital
  • CHU Grenoble-Alpes
  • CHU de Rouen
  • CHU Toulouse
  • LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic
  • Infectious diseases, AIDS and Clinical Immunology Research Center
  • LTD Academician Nikoloz Kipshidze Central University Clinic
  • ZIM 1, Gastroenterologie, University Hospital Frankfurt
  • Medizinische Hochschule Hannover
  • Universitätsmedizin Mainz, I. Med. Klinik
  • The Liver Diseases Center, Sheba Medical Center
  • Emek Medical Center
  • Soroka University Medical Center
  • Rambam Health Care Center
  • Hadassah University Hospital - Ein Kerem
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliero Universitaria Pisana
  • Institutul de Cardiologie Chisinau
  • Fundeni Clinical Institute
  • National Institute for Infectious Diseases "Matei Bals"
  • Dr. Victor Babes Foundation
  • Spitalul de Infectioase Galati Romania
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Fundación Alcorcón
  • Hospital Universitario Virgen del Rocío
  • Ankara City Hospital
  • Hacettepe University Medical Faculty
  • Ege University Medical Faculty
  • Dicle University, Medical Faculty
  • Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine
  • Koc University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peginterferon Lambda for 48 weeks

No treatment for 12 weeks

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 27, 2021
Last Updated
August 23, 2023
Sponsor
Eiger BioPharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05070364
Brief Title
Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV
Acronym
LIMT-2
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eiger BioPharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis Delta Virus
Keywords
HDV, Hepatitis D, Viral Hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peginterferon Lambda for 48 weeks
Arm Type
Experimental
Arm Description
Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up
Arm Title
No treatment for 12 weeks
Arm Type
No Intervention
Arm Description
No treatment for 12 weeks followed by Peginterferon Lambda 180 mcg once weekly for 48 weeks and 24 weeks follow-up
Intervention Type
Drug
Intervention Name(s)
Peginterferon Lambda-1a
Other Intervention Name(s)
Lambda, Peginterferon Lambda, Pegylated Interferon Lambda
Intervention Description
Immunomodulator
Primary Outcome Measure Information:
Title
Durable Virologic Response
Description
HDV RNA below the limit of quantitation at 24 weeks post-treatment
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Asian Pacific Liver Center at Coalition of Inclusive Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford Medicine Outpatient Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Sutter Pacific Medical Foundation - California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
NYU Langone Health / NYU Grossman School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine - Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
CUB Hôpital Erasme
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
Acibadem City Clinic Tokuda Hospital
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Centre" EOOD
City
Stara Zagora
ZIP/Postal Code
6001
Country
Bulgaria
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Clermont-Ferrand Cedex
ZIP/Postal Code
63100
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34000
Country
France
Facility Name
APHP, Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Henri-Mondor Hospital
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU Grenoble-Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Infectious diseases, AIDS and Clinical Immunology Research Center
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD Academician Nikoloz Kipshidze Central University Clinic
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
ZIM 1, Gastroenterologie, University Hospital Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsmedizin Mainz, I. Med. Klinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
The Liver Diseases Center, Sheba Medical Center
City
Ramat Gan
State/Province
Tel Hashomer
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Emek Medical Center
City
Afula
ZIP/Postal Code
1834113
Country
Israel
Facility Name
Soroka University Medical Center
City
Beer-Sheba
Country
Israel
Facility Name
Rambam Health Care Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
City
Foggia
Country
Italy
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Institutul de Cardiologie Chisinau
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Fundeni Clinical Institute
City
Bucharest
Country
Romania
Facility Name
National Institute for Infectious Diseases "Matei Bals"
City
Bucharest
Country
Romania
Facility Name
Dr. Victor Babes Foundation
City
Bucuresti
ZIP/Postal Code
030303
Country
Romania
Facility Name
Spitalul de Infectioase Galati Romania
City
Galati
Country
Romania
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Fundación Alcorcón
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dicle University, Medical Faculty
City
Diyarbakır
ZIP/Postal Code
21280
Country
Turkey
Facility Name
Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Koc University Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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