A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection

• Status: Completed
• Trial end date: 2018-06-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• Male or female children, <13 years of age

• Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral culture positive for influenza

• Immunocompromised

• Symptoms/signs suggestive of influenza like illness (ILI)

• Less than or equal to ( Exclusion Criteria:

• Clinical evidence of severe hepatic impairment

• Infants with post-menstrual age (PMA) <36 weeks

• Clinical evidence of significant renal impairment

• Allergy to oseltamivir or excipients

• Hereditary fructose intolerance

• Received anti-viral treatment with activity against influenza (for example amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization