Respiratory Syncytial Virus InfectionPhase 3NCT01466062
Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions
A Phase 3 study testing Palivizumab in people with Respiratory Syncytial Virus Infection, run by AbbVie (prior sponsor, Abbott) at 6 sites in Japan.
Trial summary
To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- What is being tested?
- Palivizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesJapan
- Study dates
- Aug 2011to Apr 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Japanese newborn, infant or young child at age of 24 months or less.
- 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:
- 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
- Subject has been diagnosed with human immunodeficiency virus infection, or
- 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
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- Subject has a history of post organ transplantation at the time of informed consent, or
- Subject has a history of post bone marrow transplantation at the time of informed consent, or
- Subject is receiving immunosuppressive chemotherapy at the start of study drug administration, or
- 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
- Subject is receiving other immunosuppressive therapy (azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc.) at the start of study drug administration.
Who cannot join
- 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.
- 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.
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- Subject has a current active infection including respiratory syncytial virus infection at Screening and at the start of study drug administration.
- Subject has a serious concurrent medical condition (hepatic dysfunction, persistent seizure disorder, etc.) except those resulting in an immune deficiency condition or renal failure.
- Subject has received palivizumab prior to the study drug administration.
- 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).
- Subject has a history of an allergic reaction or hypersensitivity to constituents of the study drug.
- 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.
- Subject whose remaining days of life are expected to be less than one year at the time of informed consent.
- It will be impossible to collect blood as scheduled from the subject.
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Site Reference ID/Investigator# 56847
Hyōgo
Site Reference ID/Investigator# 56845
Shimotsuke
Site Reference ID/Investigator# 56842
Tokyo
Site Reference ID/Investigator# 56844
Tokyo
Site Reference ID/Investigator# 56846
Tokyo
Site Reference ID/Investigator# 56843
Yokohama
About this study
Official title: 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.
- Conditions
- Respiratory Syncytial Virus Infection
- Being tested
- Palivizumab
- Keywords
- Immunocompromised medical conditions, Respiratory Syncytial Virus Infection, Infant, Newborn, Young children
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalivizumabDrug
Also called ABT-315, Synagis
| Study group | Role | What they receive |
|---|---|---|
| Palivizumab | Experimental | 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. Receives: Drug: Palivizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Palivizumab Trough Concentrations at Day 1, Day 31, and 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).
Measured: Day 1 (Screening), Day 31, Day 121
Secondary outcomes (17)
Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection
Measured: 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
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.
Measured: 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
Number of days of hospitalization caused by RSV infection.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Measured: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121
Measured: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121
Measured: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121
Measured: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Mean Baseline and Mean Change From Baseline in Body Weight at Day 121
Measured: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121
Normal range for hemoglobin varied by the monthly age of the participant.
Measured: Baseline (Day 1), Day 121 (30 days after the 4th dose)
Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121
Normal range for hematocrit varied by the monthly age of the participant.
Measured: 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
Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.
Measured: 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
Normal ranges for RBC and platelet count varied by the monthly age of the participant.
Measured: 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
Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant.
Measured: 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
Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant.
Measured: 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
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.
Measured: Screening, Day 121 (30 days after the 4th dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeki Hashimoto, PhD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466062
- Sponsor's protocol ID
- M12-420
- Status last verified
- Jun 2013
- First submitted
- 12 Sep 2011
- Last updated
- 17 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01466062
- Acronym / sponsor ID
- M12-420
- Conditions
- Respiratory Syncytial Virus Infection
- Keywords
- Immunocompromised medical conditions, Respiratory Syncytial Virus Infection, Infant, Newborn, Young children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Posted 17 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palivizumab | Experimental | Drug: Palivizumab15 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
- Japanese newborn, infant or young child at age of 24 months or less.
- 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:
Key exclusion criteria (15 listed)
- Subject who meets one of the palivizumab indications already approved in Japan.
- 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.
- Subject has a current active infection including respiratory syncytial virus infection at Screening and at the start of study drug administration.
- Subject has a serious concurrent medical condition (hepatic dysfunction, persistent seizure disorder, etc.) except those resulting in an immune deficiency condition or renal failure.
- Subject has received palivizumab prior to the study drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalivizumabAlso: ABT-315, Synagis | Drug | Palivizumab |
Primary outcome
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).
17 secondary outcomes
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.
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.
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.
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.
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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related infoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeki Hashimoto, PhD study director
AbbVie
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palivizumab in people with Respiratory Syncytial Virus Infection, run by AbbVie (prior sponsor, Abbott) at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121 (time frame: Day 1 (Screening), Day 31, Day 121). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.