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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002633-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oseltamivir: Standard dose | Experimental | Participants 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). |
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| Oseltamivir: Triple dose | Experimental | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Steady State Area Under the Concentration-Time Curve From Time 0 to 12 Hours (AUC0-12) of Oseltamivir | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 | |
| Steady State AUC0-12 of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 | |
| Maximum Plasma Concentration (Cmax) of Oseltamivir | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 | |
| Cmax of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 | |
| Trough Plasma Concentration (Ctrough) of Oseltamivir | Pre-dose (within 30 minutes prior to administration) on Days 3 or 4 | |
| Ctrough of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration) on Days 3 or 4 | |
| Time to Cessation of Viral Shedding, as Assessed by Polymerase Chain Reaction (PCR) or Culture Testing | From randomization to negative PCR/culture test result (up to Day 50) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolution of Influenza Symptoms (including fever),, as Assessed by Canadian Acute Respiratory Infections Scale (CARIFS) | From randomization to resolution of all influenza symptoms (up to Day 50) | |
| Number of Participants With Adverse Events | Baseline up to Day 50 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Child Hosp; Pediatric Pulmonary Division | Palo Alto | California | 94304 | United States | ||
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| Number of Participants With Influenza Associated Complications | Baseline up to Day 50 |
| Number of Participants With Viral Resistance | Baseline up to Day 50 |
| Half-life (t1/2) of Oseltamivir | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| t1/2 of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Time to Maximum Concentration (Tmax) of Oseltamivir | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Tmax of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Elimination Rate Constant (Ke) of Oseltamivir | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Ke of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Apparent Volume of Distribution (V/F) of Oseltamivir | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| V/F of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Apparent Clearance (CL/F) of Oseltamivir | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| CL/F of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Time to Last Measurable Concentration (Tlast) of Oseltamivir | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Tlast of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Last Measurable Concentration (Clast) of Oseltamivir | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| Clast of Oseltamivir Carboxylate | Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4 |
| The Children's Hospital; Pediatric Infectious Diseases |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| UZ Brussel | Brussels | 1090 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Hospital Erasto Gaertner | Curitiba | Paraná | 81520-060 | Brazil |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Graacc-Grupo de Apoio ao adolescente e a crianca com cancer | São Paulo | São Paulo | 04023-062 | Brazil |
| Casa de Saúde Santa Marcelina | São Paulo | São Paulo | 08270-070 | Brazil |
| Children'S Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital For Sick Children; Infectious Disease Dept | Toronto | Ontario | M5G 1X8 | Canada |
| McGill University; Montreal Children's Hospital; Oncology | Montreal | Quebec | H4A 3J1 | Canada |
| Hospital Dr. Gustavo Fricke | Viña del Mar | 2520000 | Chile |
| Centro Medico Imbanaco | Cali | Colombia |
| Fundacion Clinica Valle de Lili, Department Rheumatology | Cali | Colombia |
| Turun yliopistollinen keskussairaala | Turku | 20520 | Finland |
| Charité - Universitätsmedizin Berlin;Klinik für Allgemeine Pädiatrie | Berlin | 13353 | Germany |
| Universitatsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| Dr. Von Haunersches Kinderspital | München | 80337 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Universitätsklinikum Tübingen UNI-Klinik für Kinder- und Jugendmedizin | Tübingen | 72076 | Germany |
| Childrens Regional Hospital Aglaia Kyriakou | Athens | 115 27 | Greece |
| Aghia Sophia Children's Hospital; Pediatric Rheumatology Unit; 1st Department of Pediatrics | Athens | 11527 | Greece |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Schneider Children's Medical Center of Israel; Pediatrics Department | Petah Tikva | 49100 | Israel |
| The Chaim Sheba Medical Center; Multiple Sclerosis Center | Ramat Gan | 52621 | Israel |
| The Dana Children's Hospital | Tel Aviv | 64239 | Israel |
| Ospedale Pediatrico Bambino Gesu | Rome | Lazio | 00165 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa Pediatria 1 | Milan | Lombardy | 20122 | Italy |
| ASST DI MONZA; Divisione Malattie Infettive | Monza | Lombardy | 20052 | Italy |
| Instituto Nacional de Pediatria; Departmento de Neurologia | México | 04530 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León | Monterrey | 64460 | Mexico |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Children Hospital, Olsztyn; Ward of Pediatric Hematology and Oncology | Olsztyn | 10-561 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego | Szczecin | 71-242 | Poland |
| Medical University of Silesia; Department of Pediatric Hematology and Oncology | Zabrze | 41-800 | Poland |
| Tygerberg Hospital; Rheumatology | Cape Town | 7500 | South Africa |
| WWCT Lakeview Hospital | Johannesburg | 1501 | South Africa |
| Chris Hani Baragwanath Hospital | Johannesburg | 2013 | South Africa |
| Hospital Sant Joan De Deu | Esplugues de Llobregas | Barcelona | 08950 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Infantil Universitario Nino Jesus | Madrid | 28009 | Spain |
| Hospital Universitario La Paz | Madrid | 280146 | Spain |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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