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InfluenzaPhase 1NCT01715909

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

A Phase 1 study testing Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 50 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 12 years
Conditions the study is for
Influenza
What is being tested?
Oseltamivir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
50 sitesin 15 countries
Study dates
22 Jan 2014to 17 Jun 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

50 sites in 15 countries.

50 sites in 15 countries

United States7 sites

  • The Children's Hospital; Pediatric Infectious Diseases

    Aurora, Colorado, 80045

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Lucile Packard Child Hosp; Pediatric Pulmonary Division

    Palo Alto, California, 94304

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

Germany5 sites

  • Charité - Universitätsmedizin Berlin;Klinik für Allgemeine Pädiatrie

    Berlin, 13353

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

  • Dr. Von Haunersches Kinderspital

    München, 80337

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitätsklinikum Tübingen UNI-Klinik für Kinder- und Jugendmedizin

    Tübingen, 72076

Other trials in Germany

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Schneider Children's Medical Center of Israel; Pediatrics Department

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center; Multiple Sclerosis Center

    Ramat Gan, 52621

  • The Dana Children's Hospital

    Tel Aviv, 64239

Other trials in Israel

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Sant Joan De Deu

    Esplugues de Llobregas, Barcelona, 08950

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009

  • Hospital Universitario La Paz

    Madrid, 280146

Other trials in Spain

Brazil4 sites

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Graacc-Grupo de Apoio ao adolescente e a crianca com cancer

    São Paulo, São Paulo, 04023-062

  • Casa de Saúde Santa Marcelina

    São Paulo, São Paulo, 08270-070

Other trials in Brazil

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Children Hospital, Olsztyn; Ward of Pediatric Hematology and Oncology

    Olsztyn, 10-561

  • Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego

    Szczecin, 71-242

  • Medical University of Silesia; Department of Pediatric Hematology and Oncology

    Zabrze, 41-800

Other trials in Poland

Belgium3 sites

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Canada3 sites

  • McGill University; Montreal Children's Hospital; Oncology

    Montreal, Quebec, H4A 3J1

  • Children'S Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Hospital For Sick Children; Infectious Disease Dept

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Italy3 sites

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa Pediatria 1

    Milan, Lombardy, 20122

  • ASST DI MONZA; Divisione Malattie Infettive

    Monza, Lombardy, 20052

  • Ospedale Pediatrico Bambino Gesu

    Rome, Lazio, 00165

Other trials in Italy

South Africa3 sites

  • Tygerberg Hospital; Rheumatology

    Cape Town, 7500

  • WWCT Lakeview Hospital

    Johannesburg, 1501

  • Chris Hani Baragwanath Hospital

    Johannesburg, 2013

Other trials in South Africa

Colombia2 sites

  • Centro Medico Imbanaco

    Cali

  • Fundacion Clinica Valle de Lili, Department Rheumatology

    Cali

Other trials in Colombia

Greece2 sites

  • Childrens Regional Hospital Aglaia Kyriakou

    Athens, 115 27

  • Aghia Sophia Children's Hospital; Pediatric Rheumatology Unit; 1st Department of Pediatrics

    Athens, 11527

Other trials in Greece

Mexico2 sites

  • Instituto Nacional de Pediatria; Departmento de Neurologia

    México, 04530

  • Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

    Monterrey, 64460

Other trials in Mexico

Chile1 site

  • Hospital Dr. Gustavo Fricke

    Viña del Mar, 2520000

Other trials in Chile

Finland1 site

  • Turun yliopistollinen keskussairaala

    Turku, 20520

Other trials in Finland

About this study

Official 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

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.

Conditions
Influenza
Being tested
Oseltamivir
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OseltamivirDrug

    Also called Tamiflu

    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.

Study groups in NCT01715909
Study groupRoleWhat they receive
Oseltamivir: Standard doseExperimentalParticipants 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).
Receives: Drug: Oseltamivir
Oseltamivir: Triple doseExperimentalParticipants 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.
Receives: Drug: Oseltamivir

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

  6. Ctrough of Oseltamivir Carboxylate

    Measured: 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

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

Secondary outcomes (18)

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

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

  2. Number of Participants With Adverse Events

    Measured: Baseline up to Day 50

  3. Number of Participants With Influenza Associated Complications

    Measured: Baseline up to Day 50

  4. Number of Participants With Viral Resistance

    Measured: Baseline up to Day 50

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2012 (estimated)
  2. Study start22 Jan 2014
  3. Primary completion17 Jun 2018
  4. Study completion17 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01715909
Sponsor's protocol ID
NV25719
Other IDs
2012-002633-11
Status last verified
Oct 2018
First submitted
25 Oct 2012
Last updated
16 Oct 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 50 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Germany, Israel, Spain, Brazil and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01715909.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.

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