For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. 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
  2. Quantifiable HDV RNA by RT-PCR test at Screening Visit 2
  3. 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
  4. Serum ALT > upper limit of normal (ULN) and < 10 × ULN.
  5. Patients categorized with Child-Turcotte-Pugh score of ≤ 5 with well compensated liver disease.


Exclusion Criteria:

  1. History or current evidence of decompensated liver disease (episodes of bleeding esophageal or gastric varices, ascites and/or encephalopathy)
  2. Treatment with interferons (IFNs) or immunomodulators within 6 months before Screening Visit 2 or refractory to prior IFN treatment.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Hepatitis Delta Virus

Age (in years)

18 - 70


Phase 3

Participants needed


Est. Completion Date

Jan 15, 2025

Treatment type



Eiger BioPharmaceuticals identifier


Study number


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