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NCT01715909 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection
A Phase 1 study of Influenza, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 20
- Study locations
NCT01715909: Completed Phase 1 study of Influenza, sponsored by Hoffmann-La Roche.
NCT01715909 is a Phase 1 study of Influenza that has completed, run by Hoffmann-La Roche. The registered enrollment target is 20 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01715909, a Phase 1 study of Influenza, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 20
- Study locations
Study Summary
This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children, less than (\<) 13 years of age, with confirmed influenza infection. Participants will be randomized to receive either the standard dose or triple dose of oseltamivir orally daily for a minimum of 5 days and up to 20 days. Infants \<1 year of age will be randomized to the standard dose arm only.
Conditions Studied
Interventions
- DRUG Oseltamivir
Study Locations (20)
Other
- UZ Brussel - Brussels
- Cliniques Universitaires St-Luc - Brussels
- UZ Leuven Gasthuisberg - Leuven
- Hospital Dr. Gustavo Fricke - Viña del Mar
- Centro Medico Imbanaco - Cali
- Fundacion Clinica Valle de Lili, Department Rheumatology - Cali
São Paulo
- Graacc-Grupo de Apoio ao adolescente e a crianca com cancer - São Paulo
- Casa de Saúde Santa Marcelina - São Paulo
Ontario
- Children'S Hospital of Eastern Ontario - Ottawa
- Hospital For Sick Children; Infectious Disease Dept - Toronto
California
- Lucile Packard Child Hosp; Pediatric Pulmonary Division - Palo Alto
Colorado
- The Children's Hospital; Pediatric Infectious Diseases - Aurora
Massachusetts
- Tufts Medical Center - Boston
Minnesota
- University of Minnesota - Minneapolis
New York
- SUNY Upstate Medical University - Syracuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-01-22 |
| Est. Completion | 2018-06-17 |
| Phase | Phase 1 |
What the finished NCT01715909 record still lists
NCT01715909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Oseltamivir is the first listed.
NCT01715909 names 20 study sites across 13 states, led by Other, São Paulo, Ontario.
Frequently Asked Questions
What is clinical trial NCT01715909 about?
NCT01715909 is a clinical study titled "A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection". This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children, less than (\<) 13 years of age, with confirmed influenza infection. Participants will be randomized to receive either the st...
What is the current status of trial NCT01715909?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-01-22. Estimated completion is 2018-06-17.
What conditions does trial NCT01715909 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01715909?
The interventions under investigation include: Oseltamivir (DRUG).
Who is sponsoring clinical trial NCT01715909?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01715909 being conducted?
This trial has 20 study locations across California, Colorado, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01715909's enrollment target sits among peer trials
20 150th of 156 higher than 6 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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.
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