Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a
Public ClinicalTrials.gov record NCT03719313. 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
A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID With and Without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared With PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected With Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)Ide Therapy (D-LIVR)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.
Study identification
- NCT ID
- NCT03719313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 407 participants
Conditions and interventions
Conditions
Interventions
- Lonafarnib Drug
- Ritonavir Drug
- PEG IFN-alfa-2a Drug
- Placebo Lonafarnib Drug
- Placebo Ritonavir Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 1, 2018 (Actual)
- Primary completion
- Oct 6, 2022 (Actual)
- Completion
- Mar 24, 2023 (Actual)
- Last update posted
- Apr 14, 2023
2018 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Fresno | Fresno | California | 93701 | — |
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | — |
| Asia Pacific Liver Center | Los Angeles | California | 90057 | — |
| Stanford University | Palo Alto | California | 94303 | — |
| University of California Davis Health System | Sacramento | California | 95817 | — |
| Kaiser Permanente Medical Center Sacramento | Sacramento | California | 95825 | — |
| Yale University Medical Center | New Haven | Connecticut | 06510-3206 | — |
| University of Miami Schiff Center for Liver Disease | Miami | Florida | 33136 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| National Institutes of Health | Bethesda | Maryland | 20814 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Mt. Sinai Hospital | New York | New York | 10029 | — |
| NYU Langone Medical Center | New York | New York | 11016 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Central Sooner Research | Norman | Oklahoma | 73071 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8857 | — |
| Baylor St. Luke's Medical Center | Houston | Texas | 77030 | — |
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 98 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03719313, 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 Apr 14, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03719313 live on ClinicalTrials.gov.