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NCT01165580 · ClinicalTrials.gov registry record · Phase 1
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01165580 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 17 participants.
The verdict
NCT01165580, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients \< 4 months of age.
Interventions
- DRUG valganciclovir [Valcyte]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01165580
The ClinicalTrials.gov registry entry for NCT01165580 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which valganciclovir [Valcyte] is the first listed.
NCT01165580 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01165580 about?
NCT01165580 is a clinical study titled "A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age". This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients \< 4 months of age.
What is the current status of trial NCT01165580?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2011-05. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01165580?
The interventions under investigation include: valganciclovir [Valcyte] (DRUG).
Who is sponsoring clinical trial NCT01165580?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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