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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 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 57 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01376804
The ClinicalTrials.gov registry entry for NCT01376804 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 57 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.
NCT01376804 reports 0 study locations.
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.
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