Suppression of serious lower respiratory tract disease for neonates, infants, and preschool children with any of the following disease groups
Conditions
Interventions
investigational material(s)
Generic name etc : Palivizumab (Genetical Recombination)
INN of investigational material : Palivizumab
Therapeutic category code : 625 Anti-virus agents
Dosage and Administ
Sponsors
Mori Masaaki, MD, Ph.D.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The trial will include those who meet all the following items. (1) The legally acceptable representative of the child has provided written informed consent to the protocol treatment and examination in the trial. (2) The child is 24 months of age when the consent is provided. (3) When the consent is provided, the child has a disease classified into any of the following diseases groups, which would be associated with reduced ventilation competence or difficulty in expectoration, if RS virus infection occurs, resulting in exacerbation of the infection, and is judged to be in need of prophylactic administration of palivizumab by the investigator or coinvestigator - Pulmonary hypoplasia - Airway stenosis - Congenital esophageal atresia - Congenital metabolic disorder - Neuromuscular disease (4) When the consent is provided, the child is a pediatric patient under continuous ambulatory management
Exclusion criteria
Exclusion criteria: This trial will exclude those who meet any of the following items. (1) At the baseline, the child falls under any of the following categories who may receive palivizumab under the exiting approval. 1) Neonates and infants == 2 weeks may be included. (6) The child has serious complications (hepatic failure, tonic convulsion, etc.) other than immunodeficiency and renal failure. (7) The child has a history of apnea. (8) The child has a history of hypersensitivity to any component of the investigational product. (9) The child has a history of serious adverse drug reactions related to immunoglobulin preparations or a history of serious allergy to such preparations. The child has a history of hypersensitivity to immunoglobulin, blood, or the other protein preparations. (10) The child is not expected to survive for >= 1 year after the first dose of the investigational product. (11) The child is judged to be inappropriate for participation in this trial for the other reasons by the investigator or coinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The following endpoints are set in this trial. Because this trial is to include pediatric patients with rare diseases, the target sample size is set as at least 18, including at least 3 for each of 5 disease groups and additional count in consideration of dropouts. The efficacy results in this trial, therefore, will be comprehensively evaluated in combination with results on the following efficacy, safety, and pharmacokinetics. (1) Efficacy endpoints Percentage of subjects that require RSV-related hospitalization from the first dose of palivizumab to 30 days after the last dose | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy (1) Efficacy endpoints Percentage of subjects that require oxygen inhalation, artificial ventilation, membrane oxygenator, continuous positive airway pressure, the other assisted ventilation, or management in an intensive care unit (ICU) owing to RS virus infection from the first dose of palivizumab to 30 days after the last dose efficacy (1) Efficacy endpoints Duration in which hospitalization, oxygen inhalation, artificial ventilation, membrane oxygenator, continuous positive airway pressure, the other assisted ventilation, or management in an ICU is required safety (2) Safety endpoints Adverse events and adverse drug reactions will be tabulated in terms of the number of subjects with events/reactions, incidence and number of events/reactions by seriousness, severity, and time frame of the onset. In addition, vital signs (pulse rate, blood pressure, respiratory rate, body temperature), body weight, and laboratory values will be evaluated. pharmacokinetics (3) Pharmacokinetics (optional) Serum palivizumab concentrations (trough values) 30 days after the first dose of palivizumab, after the 4th dose, and after the last dose | — |
Countries
Japan
Contacts
Public ContactMinoru Imai
Tokyo Medical and Dental University
Outcome results
None listed