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NCT03443869 · ClinicalTrials.gov registry record · Phase 3
Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 601
- Enrollment target
NCT03443869 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 601 participants.
The verdict
NCT03443869, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 601 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.
Interventions
- DRUG Letermovir
- DRUG Valganciclovir
- DRUG Acyclovir (ACV)
- DRUG Placebo to ACV
- DRUG Placebo to LET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2018-05-03 |
| Est. Completion | 2022-04-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03443869
The ClinicalTrials.gov registry entry for NCT03443869 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 601 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Letermovir is the first listed.
NCT03443869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03443869 about?
NCT03443869 is a clinical study titled "Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)". The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior ...
What is the current status of trial NCT03443869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2018-05-03. Estimated completion is 2022-04-05.
What interventions are being tested in trial NCT03443869?
The interventions under investigation include: Letermovir (DRUG), Valganciclovir (DRUG), Acyclovir (ACV) (DRUG), Placebo to ACV (DRUG), Placebo to LET (DRUG).
Who is sponsoring clinical trial NCT03443869?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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