- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00508651
A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age
28 de noviembre de 2011 actualizado por: MedImmune LLC
An Expanded Phase1/2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-560, A Live, Attenuated Recombinant Parainfluenza Virus Type 3 (PIV3) Vaccine, Administered Intranasally to Healthy Infants 1 to <12 Mos. of Age
The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10^5 TCID50 when administered to children 6 to < 12 months of age who are HPIV3 (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to < 3 months of age regardless of baseline serostatus.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized, double-blind, placebo-controlled, multidose Phase 1/2a multicenter study designed to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic stability of MEDI-560 in infants 1 to < 12 months of age.
Three doses of MEDI-560 at a dosage level of 10^5 TCID50 were administered 0, 2, and 4 months after enrollment to a 30-participant cohort of 6 to < 12 month-old HPIV3 seronegative children randomized 2:1 to MEDI-560 vs placebo.
A second 160-participant cohort of 1 to < 3 month-old infants not screened for baseline serostatus was planned but was not opened to enrollment for reasons other than safety.
Participants were followed for safety through 180 days post last dose.
Nasal wash specimens were collected at screening and Days 7, 12, and 28 following each dose and during unscheduled illness visits to assess vaccine virus shedding and genotypic and phenotypic stability of any shed vaccine virus.
Blood was collected at screening to determine eligibility and prior to Dose 1 for baseline serostatus.
Blood for assessment of antibodies to HPIV3 was collected approximately 7 to 12 days after Dose 1 and Dose 3 and 1 month after each dose for antibodies to PIV3.
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arkansas
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Bentonville, Arkansas, Estados Unidos, 72712
- Children's Investigational Research Program
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Little Rock, Arkansas, Estados Unidos, 72205
- Arkansas Pediatric Clinic
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California
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Madera, California, Estados Unidos, 93637
- Madera Family Medical Group
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Roseville, California, Estados Unidos, 95678
- Allergy Medical Group of the North Area
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Florida
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Miami, Florida, Estados Unidos, 33155
- Miami Children's Hospital
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Naranja, Florida, Estados Unidos, 33032
- Homestead Clinical Research
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida College of Medicine Department of Pediatrics
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96826-1032
- Kapiolani Medical Center for Women and Children
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- Michael W. Simon, M.D.
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts-New England Medical Center
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68134
- Meridian Clinical Research LLC
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89107
- Children's Lung Specialists Ltd.
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New York
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Duke Health Center- Pickett Road
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Case Medical Center
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74127
- Oklahoma State University Center for Health Sciences
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Pennsylvania
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Bethlehem, Pennsylvania, Estados Unidos, 18015
- St. Luke's Hospital
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Pittsburgh, Pennsylvania, Estados Unidos, 15202
- Belleview Pediactric Assoc.
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Tennessee
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Kingsport, Tennessee, Estados Unidos, 37660
- Holston Medical Group
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Utah
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St. George, Utah, Estados Unidos, 84790
- Dixie Pediatrics
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West Virginia
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Huntington, West Virginia, Estados Unidos, 25701
- University Physicians Internal Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 mes a 11 meses (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Male or female whose age on the day of randomization falls within one of the two age cohorts:
Cohort 1: 6 to < 12 months (≥ 6 months of age and not yet reached their 1st year birthday); Cohort 2: 1 to < 3 months (> 28 days of age and not yet reached their 3rd month birthday)
- Cohort 1 only: Participant is seronegative to HPIV3 at screening as determined by ELISA; or the legal representative is willing to provide access to data documenting that the participant was screened for another MedImmune trial after written informed consent was obtained, and that the participant is seronegative to HPIV3 within 21 days prior to randomization into MI-CP150 as determined by ELISA at MedImmune
- Participant was the product of a normal full term pregnancy, defined as 36-42 weeks gestation
- Participant is in general good health
- Participant's legal representative is available by telephone
- Written informed consent and Health Insurance Portability and Accountability Act authorization (if applicable) obtained from the participant's legal representative
- Participant's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
- Participant is available to complete the follow-up period of 180 days after the final dose of investigational product as required by the protocol
- Participant's legal representative is willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol
Exclusion Criteria:
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
- Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of investigational product
- Cohort 1 only: weight < the fifth percentile for age on the day of randomization
- Cohort 2 only: history of low birth-weight (ie, < 2,500 grams at birth) or weight < fifth percentile for age on the day of randomization
- Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each investigational product dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator
- Any current or expected receipt of immunosuppressive agents including steroids (≥ 2 mg/kg per day of prednisone or its equivalent, or ≥ 20 mg/day if the participant weighs >10 kg, given daily or on alternate days for ≥ 14 days); children in this category should not receive investigational product until immunosuppressive agents including corticosteroid therapy have been discontinued for ≥ 30 days; the use of topical steroids is permitted according to the judgment of the investigator
- History of receipt of blood transfusion or expected receipt through 30 days after final investigational product dosing
- History of receipt of immunoglobulin products or expected receipt through 30 days after final investigational product dosing
- Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final investigational product dosing
- Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any dose
- Receipt of any inactivated (eg, non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any dose
- Known or suspected immunodeficiency, including human immunodeficiency virus
- Living in the same home or enrolled in the same classroom at day care with infants < 24 months of age within 28 days after each dose (only one child per household may be enrolled into the study)
- Contact with pregnant caregiver within 28 days after each dose
- Household contact with an immunocompromised person within 28 days after each dose; the participant should also avoid close contact with immunocompromised individuals for at least 28 days after each investigational product dose
- Household contact within 28 days after each dose with a healthcare worker who has direct patient care responsibilities or household contact within 28 days after each dose with someone who is a day care provider or preschool teacher for children < 24 months of age
- History of allergic reaction to any component of the investigational product
- Previous medical history or evidence of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the participant
- Known or suspected active or chronic hepatitis infection
- History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, bronchoconstriction or treatment with a β2 agonist (eg, albuterol), cystic fibrosis, chronic lung disease of prematurity (eg, bronchopulmonary dysplasia), chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
- A family member or a household contact who is an employee of the research center or otherwise involved with the conduct of the study
- Any condition that, in the opinion of the investigator, might interfere with investigational product evaluation
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cohort 1 MEDI-560
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson^TM Luer slip tip syringes.
Each 0.2 mL dose contained 10^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.
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MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson^TM luer slip tip syringes.
Each 0.2 mL dose contained 10^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.
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Comparador de placebos: Cohort 1 Placebo
Placebo was a frozen preparation filled into Becton Dickinson^TM Luer slip-tip syringes.
Each 0.2 mL dose contained sucrose phosphate buffer.
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Placebo was a frozen preparation filled into Becton Dickinson^TM luer slip-tip syringes.
Each 0.2 mL dose contained sucrose phosphate buffer.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Solicited Adverse Events (SEs) After Dose 1
Periodo de tiempo: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants With SEs After Dose 2
Periodo de tiempo: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants With SEs After Dose 3
Periodo de tiempo: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Participants With Adverse Events (AEs) After Dose 1
Periodo de tiempo: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
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Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants With AEs After Dose 2
Periodo de tiempo: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
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Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants With AEs After Dose 3
Periodo de tiempo: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
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Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Periodo de tiempo: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants With MA-LRIs After Dose 2
Periodo de tiempo: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants With MA-LRIs After Dose 3
Periodo de tiempo: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Participants With Serious Adverse Events (SAEs) After Dose 1
Periodo de tiempo: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Days 0-28 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants With SAEs After Dose 2
Periodo de tiempo: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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One participant had event of pneumonia after Dose 2.
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Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants With SAEs After Dose 3
Periodo de tiempo: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Participants With Significant New Medical Conditions (SNMCs)
Periodo de tiempo: Day 0 through 180 days after final dose
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A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
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Day 0 through 180 days after final dose
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Periodo de tiempo: Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.
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Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
Periodo de tiempo: Days 7-10 after Dose 1 (Dose 1 was on Day 0)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 7-10 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
Periodo de tiempo: Days 12-18 after Dose 1 (Dose 1 was on Day 0)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 12-18 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1
Periodo de tiempo: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 28-34 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1
Periodo de tiempo: Days 0-34 after Dose 1 (Dose 1 was on Day 0)
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Days 0-34 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2
Periodo de tiempo: Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2
Periodo de tiempo: Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2
Periodo de tiempo: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2
Periodo de tiempo: Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3
Periodo de tiempo: Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3
Periodo de tiempo: Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3
Periodo de tiempo: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.
Periodo de tiempo: Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1
Periodo de tiempo: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
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Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline.
Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
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Days 28-34 after Dose 1 (Dose 1 was on Day 0)
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Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2
Periodo de tiempo: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
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Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline.
Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
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Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
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Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3
Periodo de tiempo: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline.
Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
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Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable
Periodo de tiempo: Day 0 after Dose 1 to 180 days after the final dose
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A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication.
Genotypic stability of recovered vaccine-type virus at the 15 mutations of phenotypic importance was assessed.
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Day 0 after Dose 1 to 180 days after the final dose
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Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable
Periodo de tiempo: Day 0 after Dose 1 to 180 days after the final dose
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A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication.
Determination of the temperature sensitivity of recovered vaccine-type virus.
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Day 0 after Dose 1 to 180 days after the final dose
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Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline
Periodo de tiempo: Baseline (Day 0 prior to Dose 1)
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Pre-dose GMT of HAI antibody to HPIV3
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Baseline (Day 0 prior to Dose 1)
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Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1
Periodo de tiempo: Day 28-34 after Dose 1 (Dose 1 was on Day 0)
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Post-Dose 1 GMT of HAI antibody to HPIV3
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Day 28-34 after Dose 1 (Dose 1 was on Day 0)
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Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2
Periodo de tiempo: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
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Post-Dose 2 GMT of HAI antibody to HPIV3
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Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
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Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3
Periodo de tiempo: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Post-Dose 3 GMT of HAI antibody to HPIV3
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Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Judith Falloon, MD, MedImmune LLC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2007
Finalización primaria (Actual)
1 de abril de 2009
Finalización del estudio (Actual)
1 de abril de 2009
Fechas de registro del estudio
Enviado por primera vez
27 de julio de 2007
Primero enviado que cumplió con los criterios de control de calidad
27 de julio de 2007
Publicado por primera vez (Estimar)
30 de julio de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de diciembre de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
28 de noviembre de 2011
Última verificación
1 de noviembre de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MI-CP150
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre MEDI-560
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