Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV
Public ClinicalTrials.gov record NCT05070364. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05070364
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 21, 2021 (Actual)
- Primary completion
- Jun 15, 2024 (Estimated)
- Completion
- Jan 15, 2025 (Estimated)
- Last update posted
- Aug 25, 2023
2021 – 2025
United States locations
- U.S. sites
- 7
- U.S. states
- 3
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Asian Pacific Liver Center at Coalition of Inclusive Medicine | Los Angeles | California | 90020 | — |
| Keck Medical Center of USC | Los Angeles | California | 90033 | — |
| Stanford Medicine Outpatient Center | Redwood City | California | 94063 | — |
| Sutter Pacific Medical Foundation - California Pacific Medical Center | San Francisco | California | 94109 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| 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 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05070364, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2023 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05070364 live on ClinicalTrials.gov.