Skip to main content
OpenTrials
Completed

NCT Number: NCT01715909

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cliniques Universitaires St-Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oseltamivir

Drug

Participants will receive standard dose (30 to 75 milligrams [mg]) or triple standard dose (90 to 225 mg) of oseltamivir orally daily for up to maximum of 20 days. Standard dose of oseltamivir according to weight (except infants): 30 mg twice daily for </= 15 kilograms (kg) body weight participants; 45 mg twice daily for 15 to 23 kg body weight participants; 60 mg twice daily for 23 to 40 kg body weight participants; and 75 mg twice daily for greater than (>) 40 kg body weight participants. Standard dose for infants is 3 mg/kg.

Other names: Tamiflu

Primary outcomes

  1. Steady State Area Under the Concentration-Time Curve From Time 0 to 12 Hours (AUC0-12) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  2. Steady State AUC0-12 of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  3. Maximum Plasma Concentration (Cmax) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  4. Cmax of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  5. Trough Plasma Concentration (Ctrough) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration) on Days 3 or 4

  6. Ctrough of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration) on Days 3 or 4

  7. Time to Cessation of Viral Shedding, as Assessed by Polymerase Chain Reaction (PCR) or Culture Testing

    Time frame: From randomization to negative PCR/culture test result (up to Day 50)

Secondary outcomes

  1. Time to Resolution of Influenza Symptoms (including fever),, as Assessed by Canadian Acute Respiratory Infections Scale (CARIFS)

    Time frame: From randomization to resolution of all influenza symptoms (up to Day 50)

  2. Number of Participants With Adverse Events

    Time frame: Baseline up to Day 50

  3. Number of Participants With Influenza Associated Complications

    Time frame: Baseline up to Day 50

  4. Number of Participants With Viral Resistance

    Time frame: Baseline up to Day 50

  5. Half-life (t1/2) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  6. t1/2 of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  7. Time to Maximum Concentration (Tmax) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  8. Tmax of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  9. Elimination Rate Constant (Ke) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  10. Ke of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  11. Apparent Volume of Distribution (V/F) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  12. V/F of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  13. Apparent Clearance (CL/F) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  14. CL/F of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  15. Time to Last Measurable Concentration (Tlast) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  16. Tlast of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  17. Last Measurable Concentration (Clast) of Oseltamivir

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

  18. Clast of Oseltamivir Carboxylate

    Time frame: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label, Randomized, Adaptive, Two-Arm, Multicenter Trial to Evaluate Pharmacokinetics And Pharmacodynamics of Two Doses of Oseltamivir (Tamiflu®) in The Treatment Of Influenza in Immunocompromised Children Less Than 13 Years Of Age, With Confirmed Influenza Infection

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 29, 2012
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.