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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 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 1,275 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02786537
The ClinicalTrials.gov registry entry for NCT02786537 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ribavirin is the first listed.
NCT02786537 reports 0 study locations.
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.
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