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NCT03092375 · ClinicalTrials.gov registry record · Phase 3
Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects
A Phase 3 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 3
- Development phase
- 177
- Enrollment target
NCT03092375: Completed Phase 3 study, sponsored by University of Florida.
NCT03092375 is a Phase 3 study that has completed, run by University of Florida. The registered enrollment target is 177 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03092375, a Phase 3 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 177 participants
- Enrollment target
Study Summary
The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
Primary Outcome
Number of non-cirrhotic treatment-experienced HCV genotype 1 with a NS5Ai inhibitor + SOF +/-RBV participants with undetectable HCV RNA (HCV RNA \<Lower Limit of Quantification -LLOQ) 12 weeks after completing G/P 300 mg/100 mg daily for 12 weeks (Arm A) vs. 16 weeks of G/P 300 mg/100 mg daily (Arm B)
Interventions
- DRUG Glecaprevir/Pibrentasvir (G/P) 300mg/120mg
- DRUG Ribavirin 200Mg Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2017-04-20 |
| Est. Completion | 2020-02-06 |
| Phase | Phase 3 |
What the finished NCT03092375 record still lists
NCT03092375 is an interventional study that assigns participants to a tested intervention. The registered 177 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 (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Glecaprevir/Pibrentasvir (G/P) 300mg/120mg is the first listed.
NCT03092375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03092375 about?
NCT03092375 is a clinical study titled "Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects". The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be ...
What is the current status of trial NCT03092375?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 177 participants. The study started on 2017-04-20. Estimated completion is 2020-02-06.
What interventions are being tested in trial NCT03092375?
The interventions under investigation include: Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (DRUG), Ribavirin 200Mg Tablet (DRUG).
Who is sponsoring clinical trial NCT03092375?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03092375's enrollment target sits among peer trials
177 1438th of 2000 higher than 563 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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