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NCT01611974 · ClinicalTrials.gov registry record · Phase 2
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT01611974: Completed Phase 2 study, sponsored by Shire.
NCT01611974 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01611974, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in recipients of stem cell or solid organ transplants.
Primary Outcome
Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 con
Interventions
- DRUG Maribavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2012-07-17 |
| Est. Completion | 2014-12-05 |
| Phase | Phase 2 |
What the finished NCT01611974 record still lists
NCT01611974 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 1 intervention - of which Maribavir is the first listed.
NCT01611974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01611974 about?
NCT01611974 is a clinical study titled "Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients". This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in recipients of stem cell or soli...
What is the current status of trial NCT01611974?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2012-07-17. Estimated completion is 2014-12-05.
What interventions are being tested in trial NCT01611974?
The interventions under investigation include: Maribavir (DRUG).
Who is sponsoring clinical trial NCT01611974?
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 NCT01611974's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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