Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

June 13, 2013 updated by: AbbVie (prior sponsor, Abbott)

Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hyogo, Japan
        • Site Reference ID/Investigator# 56847
      • Shimotsuke, Japan
        • Site Reference ID/Investigator# 56845
      • Tokyo, Japan
        • Site Reference ID/Investigator# 56842
      • Tokyo, Japan
        • Site Reference ID/Investigator# 56844
      • Tokyo, Japan
        • Site Reference ID/Investigator# 56846
      • Yokohama, Japan
        • Site Reference ID/Investigator# 56843

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Availability of parent or legal guardian who is capable and willing to give written informed consent for his/her newborn, infant or young child to participate this study.
  2. Japanese newborn, infant or young child at age of 24 months or less.

  3. The subject must meet at least one of the following immunocompromised medical conditions (from [a] to [h]), and must be considered by the investigator to be a suitable candidate to receive prophylactic treatment of palivizumab:

    1. Subject has been diagnosed with combined immunodeficiency (severe combined immunodeficiency, X-linked hyper-immunoglobulin M (IgM) syndrome, etc.), antibody deficiency (X-linked agammaglobulinemia, common variable immunodeficiency, non-X-linked hyper-IgM syndrome, etc.) or other immunodeficiency (Wiskott-Aldrich syndrome, DiGeorge syndrome, etc.) at the time of informed consent, or
    2. Subject has been diagnosed with human immunodeficiency virus infection, or
    3. Subject has been diagnosed with Down syndrome without a current hemodynamically significant congenital heart disease at the time of informed consent (subject must have an experience with persistent respiratory symptom or regular outpatient treatment due to respiratory tract infection prior to current RSV season), or
    4. Subject has a history of post organ transplantation at the time of informed consent, or
    5. Subject has a history of post bone marrow transplantation at the time of informed consent, or
    6. Subject is receiving immunosuppressive chemotherapy at the start of study drug administration, or
    7. Subject is receiving systemic high dose corticosteroid therapy (prednisone equivalents 0.5 mg/kg or more every other day, other than inhaler or topical use) at the start of study drug administration, or
    8. Subject is receiving other immunosuppressive therapy (azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc.) at the start of study drug administration.

Exclusion Criteria:

  1. Subject who meets one of the palivizumab indications already approved in Japan.

    • Subject born at 28 weeks of gestation or less and who is age of 12 months or less at the start of study drug administration.
    • Subject born at 29 - 35 weeks of gestation and who is age of 6 months or less at the start of study drug administration.
    • Subject is age of 24 months or less with a history of bronchopulmonary dysplasia requiring medical management within the 6 months prior to the study drug administration.
    • Subject is age of 24 months or less with a current hemodynamically significant congenital heart disease at the start of study drug administration.
  2. Subject requires oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support at Screening and at the start of study drug administration.
  3. Subject has a current active infection including respiratory syncytial virus infection at Screening and at the start of study drug administration.
  4. Subject has a serious concurrent medical condition (hepatic dysfunction, persistent seizure disorder, etc.) except those resulting in an immune deficiency condition or renal failure.
  5. Subject has received palivizumab prior to the study drug administration.
  6. Subject has received any other investigational agents in the past 3 months or 5 half lives prior to the investigational drug administration (whichever is longer).
  7. Subject has a history of an allergic reaction or hypersensitivity to constituents of the study drug.
  8. Subject has a history of serious adverse reactions or serious allergic reaction to immunoglobulin products or has a history of hypersensitivity to immunoglobulin products, blood products, or other foreign proteins.
  9. Subject whose remaining days of life are expected to be less than one year at the time of informed consent.
  10. It will be impossible to collect blood as scheduled from the subject.
  11. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Palivizumab
15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of severe respiratory syncytial virus (RSV) during the RSV season.
Drug: Palivizumab
Other Names:
  • Synagis
  • ABT-315

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121
Time Frame: Day 1 (Screening), Day 31, Day 121
Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).
Day 1 (Screening), Day 31, Day 121

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection
Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Percentage of participants who required any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection
Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Number of days of hospitalization caused by RSV infection.
From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection
Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Time Frame: From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Mean Baseline and Mean Change From Baseline in Body Weight at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Normal range for hemoglobin varied by the monthly age of the participant.
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Normal range for hematocrit varied by the monthly age of the participant.
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Normal ranges for RBC and platelet count varied by the monthly age of the participant.
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant.
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant.
Baseline (Day 1), Day 121 (30 days after the 4th dose)
Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
Time Frame: Screening, Day 121 (30 days after the 4th dose)
The values -, -/+, 1+, 2+, 3+, and 4+ represent a range from none (-) to highest (4+) presence of protein, glucose, and occult blood in the urine. Table presents the number of participants with each value. Those categories with 0 participants to report at either time point are not included in the table below.
Screening, Day 121 (30 days after the 4th dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shigeki Hashimoto, PhD, AbbVie GK.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M12-420

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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