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NCT03719313 · ClinicalTrials.gov registry record · Phase 3
Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a
A Phase 3 study, sponsored by Eiger BioPharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 407
- Enrollment target
NCT03719313: Completed Phase 3 study, sponsored by Eiger BioPharmaceuticals.
NCT03719313 is a Phase 3 study that has completed, run by Eiger BioPharmaceuticals. The registered enrollment target is 407 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03719313, a Phase 3 study, has completed, sponsored by Eiger BioPharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 407 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Ritonavir
- DRUG Lonafarnib
- DRUG PEG IFN-alfa-2a
- DRUG Placebo Lonafarnib
- DRUG Placebo Ritonavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2018-12-01 |
| Est. Completion | 2023-03-24 |
| Phase | Phase 3 |
What the finished NCT03719313 record still lists
NCT03719313 is an interventional study that assigns participants to a tested intervention. The registered 407 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.
NCT03719313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03719313 about?
NCT03719313 is a clinical study titled "Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a". 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-contai...
What is the current status of trial NCT03719313?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 407 participants. The study started on 2018-12-01. Estimated completion is 2023-03-24.
What interventions are being tested in trial NCT03719313?
The interventions under investigation include: Ritonavir (DRUG), Lonafarnib (DRUG), PEG IFN-alfa-2a (DRUG), Placebo Lonafarnib (DRUG), Placebo Ritonavir (DRUG).
Who is sponsoring clinical trial NCT03719313?
This trial is sponsored by Eiger BioPharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03719313's enrollment target sits among peer trials
407 913th of 2000 higher than 1,088 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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