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NCT02786537 · ClinicalTrials.gov registry record · Phase 4
Study of Oral Treatments for Hepatitis C
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,275
- Enrollment target
NCT02786537: Completed Phase 4 study, sponsored by University of Florida.
NCT02786537 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 1,275 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (146% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02786537, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,275 participants
- Enrollment target
Study Summary
Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.
Primary Outcome
SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation at discretion of provider). mITT with imputation (missing=failure). Total number of subjects reflects participants from EBR/GZR with or without RBV and SOF/LDV with or without RBV randomized during Phase 1 and Phase 2.
Interventions
- DRUG Ribavirin
- DRUG SOF/LDV (sofosbuvir/ledipasvir)
- DRUG PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only)
- DRUG EBR/GZR (elbasvir/grazoprevir)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,275 participants |
| Start Date | 2016-06 |
| Est. Completion | 2020-09-02 |
| Phase | Phase 4 |
What the finished NCT02786537 record still lists
NCT02786537 is an interventional study that assigns participants to a tested intervention. Its 1,275 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (146% higher).
The record links to 0 conditions, and to 4 interventions - of which Ribavirin is the first listed.
NCT02786537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02786537 about?
NCT02786537 is a clinical study titled "Study of Oral Treatments for Hepatitis C". Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approv...
What is the current status of trial NCT02786537?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,275 participants. The study started on 2016-06. Estimated completion is 2020-09-02.
What interventions are being tested in trial NCT02786537?
The interventions under investigation include: Ribavirin (DRUG), SOF/LDV (sofosbuvir/ledipasvir) (DRUG), PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only) (DRUG), EBR/GZR (elbasvir/grazoprevir) (DRUG).
Who is sponsoring clinical trial NCT02786537?
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 NCT02786537's enrollment target sits among peer trials
1,275 60th of 2000 higher than 1,941 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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