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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05070364
Recruitment Status : Recruiting
First Posted : October 7, 2021
Last Update Posted : August 23, 2022
Sponsor:
Information provided by (Responsible Party):
Eiger BioPharmaceuticals

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
Hepatitis Delta Virus 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 21, 2021
Estimated Primary Completion Date : June 15, 2024
Estimated Study Completion Date : January 15, 2025


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



Primary Outcome Measures :
  1. Durable Virologic Response [ Time Frame: 72 weeks ]
    HDV RNA below the limit of quantitation at 24 weeks post-treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05070364


Contacts
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Contact: Nicole Ramza, MBA 650-272-6138 LIMT-2@eigerbio.com
Contact: Monica Gangal, MSc 650-272-6138 LIMT-2@eigerbio.com

Locations
Show Show 53 study locations
Sponsors and Collaborators
Eiger BioPharmaceuticals
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Responsible Party: Eiger BioPharmaceuticals
ClinicalTrials.gov Identifier: NCT05070364    
Other Study ID Numbers: EIG-LMD-002
First Posted: October 7, 2021    Key Record Dates
Last Update Posted: August 23, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Hepatitis A
Hepatitis D
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents