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

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 22, 2014

Primary Completion Date

June 17, 2018

Study Completion Date

June 17, 2018

Conditions
Influenza
Interventions
DRUG

Oseltamivir

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.

Trial Locations (50)

1090

UZ Brussel, Brussels

1200

Cliniques Universitaires St-Luc, Brussels

1501

WWCT Lakeview Hospital, Johannesburg

2013

Chris Hani Baragwanath Hospital, Johannesburg

3000

UZ Leuven Gasthuisberg, Leuven

7500

Tygerberg Hospital; Rheumatology, Cape Town

11527

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

13210

SUNY Upstate Medical University, Syracuse

13353

Charité - Universitätsmedizin Berlin;Klinik für Allgemeine Pädiatrie, Berlin

20052

ASST DI MONZA; Divisione Malattie Infettive, Monza

20122

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

20520

Turun yliopistollinen keskussairaala, Turku

28007

Hospital General Universitario Gregorio Marañon, Madrid

28009

Hospital Infantil Universitario Nino Jesus, Madrid

31096

Rambam Medical Center, Haifa

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

48149

Universitätsklinikum Münster, Münster

49100

Schneider Children's Medical Center of Israel; Pediatrics Department, Petah Tikva

52621

The Chaim Sheba Medical Center; Multiple Sclerosis Center, Ramat Gan

55455

University of Minnesota, Minneapolis

60590

Universitatsklinikum Frankfurt, Frankfurt

64239

The Dana Children's Hospital, Tel Aviv

64460

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

72076

Universitätsklinikum Tübingen UNI-Klinik für Kinder- und Jugendmedizin, Tübingen

80045

The Children's Hospital; Pediatric Infectious Diseases, Aurora

80337

Dr. Von Haunersches Kinderspital, München

94304

Lucile Packard Child Hosp; Pediatric Pulmonary Division, Palo Alto

98105

Seattle Children's Hospital, Seattle

280146

Hospital Universitario La Paz, Madrid

2520000

Hospital Dr. Gustavo Fricke, Viña del Mar

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

02111

Tufts Medical Center, Boston

81520-060

Hospital Erasto Gaertner, Curitiba

90610-000

Hospital São Lucas da PUCRS, Porto Alegre

04023-062

Graacc-Grupo de Apoio ao adolescente e a crianca com cancer, São Paulo

08270-070

Casa de Saúde Santa Marcelina, São Paulo

K1H 8L1

Children'S Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital For Sick Children; Infectious Disease Dept, Toronto

H4A 3J1

McGill University; Montreal Children's Hospital; Oncology, Montreal

Unknown

Centro Medico Imbanaco, Santiago de Cali

Fundacion Clinica Valle de Lili, Department Rheumatology, Santiago de Cali

115 27

Childrens Regional Hospital Aglaia Kyriakou, Athens

00165

Ospedale Pediatrico Bambino Gesu, Rome

04530

Instituto Nacional de Pediatria; Departmento de Neurologia, México

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

10-561

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

71-242

Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego, Szczecin

41-800

Medical University of Silesia; Department of Pediatric Hematology and Oncology, Zabrze

08950

Hospital Sant Joan De Deu, Esplugues de Llobregas

08035

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01715909 - A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection | Biotech Hunter | Biotech Hunter