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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 January 2022 |
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Main ID: |
EUCTR2009-014365-12-BE |
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Date of registration:
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28/10/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu) in the treatment of infants 0 to < 12 months of age with laboratory confirmed influenza infection
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Scientific title:
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An open label, prospective, pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu) in the treatment of infants 0 to < 12 months of age with laboratory confirmed influenza infection
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Date of first enrolment:
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28/03/2011 |
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Target sample size:
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85 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014365-12 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Netherlands
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Post natal age:
• Cohort I: 3 to < 12 months
• Cohort II: 1 to < 3 months
• Cohort III: 0 to 30 days
2. Confirmed laboratory diagnosis of influenza by PCR or rapid influenza diagnostic test within 96 hours prior to first dose
3. Duration of influenza symptoms = 96 hours prior to first dose
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Post conceptual age less than 36 weeks
- Weight less than 5th percentile for age (corrected for gestation)
- concurrent gastrointestinal conditions that preclude enteric absorption of the drug
- bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrolment
- Have evidence of active or uncontrolled respiratory, cardiac, hepatic, CNS or renal
disease unrelated to influenza at baseline
- Non-study treatment with Oseltamivir for the current illness prior to first study
dose
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Treatment of influenza
MedDRA version: 12.0
Level: LLT
Classification code 10022000
Term: Influenza
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Intervention(s)
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Trade Name: Tamiflu
Product Name: oseltamivir
Product Code: Ro 64-0796
Pharmaceutical Form: Oral suspension
INN or Proposed INN: oseltamivir
CAS Number: 204255-11-8
Current Sponsor code: Tamiflu
Other descriptive name: OSELTAMIVIR PHOSPHATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
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Primary Outcome(s)
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Secondary Objective: The secondary objectives are:
• to describe the frequency of all adverse events among treated children
• to assess the clearance of virus and viral RNA
• to determine the potential for the development of resistance to oseltamivir
• to explore other pharmacodynamic parameters (e.g. resolution of fever)
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Main Objective: The primary objective is to define the pharmacokinetics of oseltamivir and oseltamivir
carboxylate in children with confirmed influenza up to one year of age.
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Primary end point(s): The primary variables are the steady-state pharmacokinetic parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate.
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Secondary ID(s)
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WP22849
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2009-014365-12-ES
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 28/03/2011
Contact:
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