Hepatitis Delta VirusPhase 3LIMT-2NCT05070364
Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV
A Phase 3 study testing Peginterferon Lambda-1a in people with Hepatitis Delta Virus, run by Eiger BioPharmaceuticals at 48 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis Delta Virus
- What is being tested?
- Peginterferon Lambda-1a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 48 sitesin 12 countries
- Study dates
- 21 Dec 2021to 15 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
48 sites in 12 countries.
48 sites in 12 countries
France8 sites
APHP, Hôpital Avicenne
Bobigny, 93000
CHU Clermont-Ferrand
Clermont-Ferrand, Clermont-Ferrand Cedex, 63100
Hôpital Beaujon
Clichy, 92110
Henri-Mondor Hospital
Créteil, 94000
CHU Grenoble-Alpes
Grenoble, 38043
Hopital Saint Eloi
Montpellier, Herault, 34000
CHU de Rouen
Rouen, 76031
CHU Toulouse
Toulouse, 31059
United States7 sites
Rush University Medical Center
Chicago, Illinois, 60612
Asian Pacific Liver Center at Coalition of Inclusive Medicine
Los Angeles, California, 90020
Keck Medical Center of USC
Los Angeles, California, 90033
NYU Langone Health / NYU Grossman School of Medicine
New York, New York, 10016
Icahn School of Medicine - Mount Sinai Medical Center
New York, New York, 10029
Stanford Medicine Outpatient Center
Redwood City, California, 94063
Sutter Pacific Medical Foundation - California Pacific Medical Center
San Francisco, California, 94109
Turkey (Türkiye)6 sites
Ankara City Hospital
Ankara
Hacettepe University Medical Faculty
Ankara
Ege University Medical Faculty
Bornova, 35100
Dicle University, Medical Faculty
Diyarbakır, 21280
Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine
Istanbul, 34098
Koc University Hospital
Istanbul
Israel5 sites
Emek Medical Center
Afula, 1834113
Soroka University Medical Center
Beersheba
Rambam Health Care Center
Haifa, 3109601
Hadassah University Hospital - Ein Kerem
Jerusalem, 91120
The Liver Diseases Center, Sheba Medical Center
Ramat Gan, Tel Hashomer, 5262000
Romania4 sites
Dr. Victor Babes Foundation
Bucharest, 030303
Fundeni Clinical Institute
Bucharest
National Institute for Infectious Diseases "Matei Bals"
Bucharest
Spitalul de Infectioase Galati Romania
Galati
Belgium3 sites
CHU Brugmann
Brussels, 1020
CUB Hôpital Erasme
Brussels, B-1070
University Hospital Antwerp
Edegem, Antwerp, 2650
Georgia3 sites
LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic
Tbilisi, 0144
Infectious diseases, AIDS and Clinical Immunology Research Center
Tbilisi, 0160
LTD Academician Nikoloz Kipshidze Central University Clinic
Tbilisi, 0160
Germany3 sites
ZIM 1, Gastroenterologie, University Hospital Frankfurt
Frankfurt, 60590
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsmedizin Mainz, I. Med. Klinik
Mainz, 55131
Italy3 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Fundación Alcorcón
Madrid
Hospital Universitario Virgen del Rocío
Seville, 41013
Bulgaria2 sites
Acibadem City Clinic Tokuda Hospital
Sofia, 1407
Medical Center "Nov Rehabilitatsionen Centre" EOOD
Stara Zagora, 6001
About this study
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)
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.
Read the 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.
- Conditions
- Hepatitis Delta Virus
- Being tested
- Peginterferon Lambda-1a
- Keywords
- HDV, Hepatitis D, Viral Hepatitis
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Lambda-1aDrug
Also called Lambda, Peginterferon Lambda, Pegylated Interferon Lambda
Immunomodulator
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon Lambda for 48 weeks | Experimental | Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durable Virologic Response
HDV RNA below the limit of quantitation at 24 weeks post-treatment
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start21 Dec 2021
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis Delta VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eiger BioPharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070364
- Sponsor's protocol ID
- EIG-LMD-002
- Acronym
- LIMT-2
- Status last verified
- Aug 2023
- First submitted
- 27 Sep 2021
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lampertico P, Anolli MP, Roulot D, Wedemeyer H. Antiviral therapy for chronic hepatitis delta: new insights from clinical trials and real-life studies. Gut. 2025 Apr 7;74(5):853-862. doi: 10.1136/gutjnl-2024-332597.
PubMed 39663120
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05070364
- Acronym / sponsor ID
- LIMT-2 / EIG-LMD-002
- Conditions
- Hepatitis Delta Virus
- Keywords
- HDV, Hepatitis D, Viral Hepatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Eiger BioPharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon Lambda for 48 weeks | Experimental | Drug: Peginterferon Lambda-1aPeginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up |
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon Lambda-1aAlso: Lambda, Peginterferon Lambda, Pegylated Interferon LambdaImmunomodulator | Drug | Peginterferon Lambda for 48 weeks |
Primary outcome
Durable Virologic Response
Time frame: 72 weeks
HDV RNA below the limit of quantitation at 24 weeks post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Derived from this study: PubMed 39663120Lampertico P, Anolli MP, Roulot D, Wedemeyer H. Antiviral therapy for chronic hepatitis delta: new insights from clinical trials and real-life studies. Gut. 2025 Apr 7;74(5):853-862. doi: 10.1136/gutjnl-2024-332597.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peginterferon Lambda-1a in people with Hepatitis Delta Virus, run by Eiger BioPharmaceuticals at 48 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in France, United States, Turkey (Türkiye), Israel, Romania and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Durable Virologic Response (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05070364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.