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
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
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.
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
Contition
Hepatitis Delta Virus
Age (in years)
18 - 70
Phase
Phase 3
Participants needed
150
Est. Completion Date
Jan 15, 2025
Treatment type
Interventional
Sponsor
Eiger BioPharmaceuticals
ClinicalTrials.gov identifier
NCT05070364
Study number
EIG-LMD-002
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