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NCT01376804 · ClinicalTrials.gov registry record · Phase 4
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 57
- Enrollment target
NCT01376804: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT01376804 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 57 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01376804, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 57 participants
- Enrollment target
Study Summary
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.
Primary Outcome
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulte
Interventions
- DRUG valganciclovir [Valcyte]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2011-07-31 |
| Est. Completion | 2013-05-31 |
| Phase | Phase 4 |
What the finished NCT01376804 record still lists
NCT01376804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which valganciclovir [Valcyte] is the first listed.
NCT01376804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01376804 about?
NCT01376804 is a clinical study titled "A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients". This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200...
What is the current status of trial NCT01376804?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 57 participants. The study started on 2011-07-31. Estimated completion is 2013-05-31.
What interventions are being tested in trial NCT01376804?
The interventions under investigation include: valganciclovir [Valcyte] (DRUG).
Who is sponsoring clinical trial NCT01376804?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01376804's enrollment target sits among peer trials
57 1209th of 2000 higher than 788 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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