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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 is a Phase 3 study that has completed, run by Eiger BioPharmaceuticals. The registered enrollment target is 407 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03719313
The ClinicalTrials.gov registry entry for NCT03719313 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 407 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eiger BioPharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.
NCT03719313 reports 0 study locations.
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.
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