Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV
Status unconfirmed · Phase 3
Conditions studied: Hepatitis Delta Virus
In brief
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.
Key facts
- Study ID
- NCT05070364
- Run by
- Eiger BioPharmaceuticals
- People needed
- 150
- Starts
- 2021-12-21
- Expected to finish
- 2025-01-15
- Last updated by the study team
- 2023-08-25
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Asian Pacific Liver Center at Coalition of Inclusive Medicine — Los Angeles, California, United States
- Keck Medical Center of USC — Los Angeles, California, United States
- Stanford Medicine Outpatient Center — Redwood City, California, United States
- Sutter Pacific Medical Foundation - California Pacific Medical Center — San Francisco, California, United States
- Rush University Medical Center — Chicago, Illinois, United States
- NYU Langone Health / NYU Grossman School of Medicine — New York, New York, United States
- Icahn School of Medicine - Mount Sinai Medical Center — New York, New York, United States
- University Hospital Antwerp — Edegem, Antwerp, Belgium
- CHU Brugmann — Brussels, Belgium
- CUB Hôpital Erasme — Brussels, Belgium
- Acibadem City Clinic Tokuda Hospital — Sofia, Bulgaria
- Medical Center "Nov Rehabilitatsionen Centre" EOOD — Stara Zagora, Bulgaria
- CHU Clermont-Ferrand — Clermont-Ferrand, Clermont-Ferrand Cedex, France
- Hopital Saint Eloi — Montpellier, Herault, France
- APHP, Hôpital Avicenne — Bobigny, France
- Hôpital Beaujon — Clichy, France
- Henri-Mondor Hospital — Créteil, France
- CHU Grenoble-Alpes — Grenoble, France
- CHU de Rouen — Rouen, France
- CHU Toulouse — Toulouse, France
- LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic — Tbilisi, Georgia
- Infectious diseases, AIDS and Clinical Immunology Research Center — Tbilisi, Georgia
- LTD Academician Nikoloz Kipshidze Central University Clinic — Tbilisi, Georgia
- ZIM 1, Gastroenterologie, University Hospital Frankfurt — Frankfurt, Germany
- Medizinische Hochschule Hannover — Hanover, Germany
Full record on ClinicalTrials.gov
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