Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation

NCT01130636 | Completed Phase 4 DMC

• 1 other identifier: MV22970
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to assess the potential exposure of neonates to oseltamivir during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast milk in breastfeeding women who are treated with oseltamivir, an anti-flu medication.

Conditions

Influenza

Keywords

oseltamivir carboxylate; oseltamivir phosphate; Tamiflu pharmacokinetics in lactating women with influenza

Outcome Measures

Primary Outcomes (1)

• Oseltamivir phosphate and oseltamivir carboxylate concentration in venous blood, breast milk/colostrums, and urine.

  For lactating women, the plasma concentrations of oseltamivir phosphate and oseltamivir carboxylate in venous blood, breast milk/colostrums, and urine measured over a 12 hour period after three days after treatment, when the steady state in oseltamivir concentrations (both active and inactive metabolites) is reached in the blood.

  12 hour period

Study Arms (1)

Tamiflu

EXPERIMENTAL

Lactating women (up to 20 subjects) who present with clinical symptoms indicative of influenza will be recruited (a maximum of 6 months period of recruitment) to receive immediate treatment with oseltamivir (Tamiflu® 75 mg hard capsules, provided free of charges for the study) at a standard dose of 75 mg twice daily. These subjects will have a 12 hour pharmacokinetic plasma, urine and breast milk study undertaken after the steady state in oseltamivir concentrations (both active and inactive metabolites will be measured) is reached in blood, i.e. after three days after treatment.

Drug: Oseltamivir

Interventions

Oseltamivir DRUG

Lactating women who present with clinical symptoms indicative of influenza will receive immediate treatment with oseltamivir (Tamiflu® 75 mg hard capsules) at a standard dose of 75 mg twice daily.

Also known as: Tamiflu® 75 mg hard capsules

Tamiflu

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is breastfeeding, or has just given birth.
• The age of the patient is at least 18 years.
• Written Informed Consent obtained from the patient.
• The patient has received a diagnosis of influenza based upon the following clinical symptoms, during a time when influenza is known to be circulating:
• fever ≥37.8oC at the time of examination or a history of fever and
• at least one respiratory symptom (cough, coryza, sore throat, rhinitis)

You may not qualify if:

• Clinical suspicion of infection with a respiratory virus other than influenza and a decision by the treating physician that treatment with oseltamivir is not indicated.
• Suspicion of invasive bacterial infection requiring immediate admission to hospital.
• β-HCG blood test
• β-HCG urine test
• ultrasound examination confirming pregnancy.
• Known or suspected immunosuppression (malignancy, transplant, immunosuppressive drugs)
• Known allergy to oseltamivir.
• Participation in any clinical trials with an investigational drug or vaccine within the previous 3 months.
• A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant and adversely affecting compliance to study drug.

Sponsors & Collaborators

• Pharmahungary Group: lead
• Hoffmann-La Roche: collaborator

Study Sites (2)

DEOEC University of Debrecen, Clinic of Obstetrics and Gynecology

Debrecen, H-4032, Hungary

Location

Selye János Hospital, Department of Obstetrics and Gynecology

Komárom, 2921, Hungary

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir; Hardness

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Mechanical Phenomena; Physical Phenomena

Study Officials

• Péter Vadász, MD

  Selye János Hospital, Department of Obstetric and Gynecology,Komárom, Széchényi u.2. H-2921, Hungary

  PRINCIPAL INVESTIGATOR

• Tamás Major, MD PhD

  DEOEC University of Debrecen, Clinic of Obstetrics and Gynecology, Debrecen, Nagyerdei krt. 98. H-4032, Hungary

  PRINCIPAL INVESTIGATOR

• Attila Pál, MD PhD DSc

  Szeged University, Faculty of Medicine Szent-Györgyi Albert Clinical Center Clinic of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Nándor Ács, MD PhD

  Semmelweis University II. Clinic of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 26, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 8, 2012

Record last verified: 2012-10

Locations

HU (2)