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

Roche

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Drug: Oseltamivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01715909

NV25719

2012-002633-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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 (</=) 96 hours between onset of ILI and first dose of study drug

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Oseltamivir: Standard dose

Experimental group

Description:

Participants will receive standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight. Infants \<1 year of age will receive oseltamivir at a dose of 3 milligrams per kilogram (mg/kg).

Treatment:

Drug: Oseltamivir

Oseltamivir: Triple dose

Experimental group

Description:

Participants will receive three times the standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight and age. Infants \<1 year will receive standard dose at 3 mg/kg.

Treatment:

Drug: Oseltamivir