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NCT02931539 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 352
- Enrollment target
NCT02931539: Completed Phase 3 study, sponsored by Shire.
NCT02931539 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 352 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02931539, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 352 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.
Primary Outcome
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration less than (\<) lower limit of quantification (LLOQ) that is, \<137 International Units per milliliter (IU/mL) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of participants with confirmed CMV viremia clearance at end of study Week 8 regardless of whether either study-assigned treatment was discontinued before the end of the stipula
Interventions
- DRUG Valganciclovir
- DRUG Maribavir
- DRUG Cidofovir
- DRUG Ganciclovir
- DRUG Foscarnet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2016-12-22 |
| Est. Completion | 2020-08-17 |
| Phase | Phase 3 |
What the finished NCT02931539 record still lists
NCT02931539 is an interventional study that assigns participants to a tested intervention. The registered 352 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 (54% lower).
The record links to 0 conditions, and to 5 interventions - of which Valganciclovir is the first listed.
NCT02931539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02931539 about?
NCT02931539 is a clinical study titled "Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir". The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.
What is the current status of trial NCT02931539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 352 participants. The study started on 2016-12-22. Estimated completion is 2020-08-17.
What interventions are being tested in trial NCT02931539?
The interventions under investigation include: Valganciclovir (DRUG), Maribavir (DRUG), Cidofovir (DRUG), Ganciclovir (DRUG), Foscarnet (DRUG).
Who is sponsoring clinical trial NCT02931539?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02931539's enrollment target sits among peer trials
352 1030th of 2000 higher than 968 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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