Respiratory Syncytial Virus (RSV)Phase 3Synagis RussiaNCT02968173
A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
A Phase 3 study testing Palivizumab in people with Respiratory Syncytial Virus (RSV), run by AbbVie.
Trial summary
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants at high risk (infants born at less than or… Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- 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
- 50 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2016to 13 Jul 2017
- 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
- Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:
- Infants born ≤ 35 weeks gestational age AND are ≤ 6 months of age at enrollment
- Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (BPD) (defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) anytime within 6 months prior to enrollment
- Infants ≤ 24 months of age at enrollment with hemodynamically significant CHD, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage hemodynamically significant CHD
Who cannot join
- Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days)
- Mechanical ventilation (including continuous positive airway pressure, CPAP) at the time of enrollment
- Life expectancy less than 6 months
- Unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated
- Active respiratory illness, or other acute infection
About this study
Official title: A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants at high risk (infants born at less than or equal to 35 weeks gestational age and less than or equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical treatment within the previous 6 months or infants less than or equal to 24 months of age with hemodynamically significant congenital heart disease [CHD]).
Read the detailed description
Participants will receive palivizumab solution for injection at 15 mg/kg by IM injection every 30 days for a minimum of 3 and a maximum of 5 injections given during anticipated periods of RSV risk in the community; the number of doses will depend on the time of enrollment during the RSV season.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- Palivizumab
- Keywords
- Bronchopulmonary dysplasia (BPD), RSV hospitalization, Palivizumab, Immunoprophylaxis, Chronic lung disease (CLD) of prematurity
- Medical subject headings
- Bronchopulmonary Dysplasia, Congenital chloride diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalivizumabDrug
Also called Synagis
Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV.
| Study group | Role | What they receive |
|---|---|---|
| Children at High Risk of severe RSV Infection | Experimental | A single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled. Receives: Drug: Palivizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With RSV Hospitalization
An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).
Measured: Approximately 6 months
Secondary outcomes (7)
Total Number of RSV-Hospitalization Days
Measured: Approximately 6 months
Percentage of Participants Who Received Supplemental Oxygen While Hospitalized
Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.
Measured: Approximately 6 months
Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement
Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.
Measured: Approximately 6 months
Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization
Measured: Approximately 6 months
Total Days of RSV-ICU Stay
Measured: Approximately 6 months
Percentage of Participants Who Received Mechanical Ventilation
Measured: Approximately 6 months
Total Days of Mechanical Ventilation During RSV-hospitalization
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start9 Nov 2016
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
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 (RSV)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joaquin Valdes, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968173
- Sponsor's protocol ID
- M15-539
- Other IDs
- 2016-000221-39, 2016
- Acronym
- Synagis Russia
- Status last verified
- Jul 2017
- First submitted
- 16 Nov 2016
- Last updated
- 13 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
- ClinicalTrials.gov ID
- NCT02968173
- Acronym / sponsor ID
- Synagis Russia / M15-539
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- Bronchopulmonary dysplasia (BPD), RSV hospitalization, Palivizumab, Immunoprophylaxis, Chronic lung disease (CLD) of prematurity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants at high risk (infants born at less than or equal to 35 weeks gestational age and less than or equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical treatment within the previous 6 months or infants less than or equal to 24 months of age with hemodynamically significant congenital heart disease [CHD]).
Detailed description
Participants will receive palivizumab solution for injection at 15 mg/kg by IM injection every 30 days for a minimum of 3 and a maximum of 5 injections given during anticipated periods of RSV risk in the community; the number of doses will depend on the time of enrollment during the RSV season.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children at High Risk of severe RSV Infection | Experimental | Drug: PalivizumabA single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:
- Infants born ≤ 35 weeks gestational age AND are ≤ 6 months of age at enrollment
- Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (BPD) (defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) anytime within 6 months prior to enrollment
- Infants ≤ 24 months of age at enrollment with hemodynamically significant CHD, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage hemodynamically significant CHD
Key exclusion criteria (5 listed)
- Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days)
- Mechanical ventilation (including continuous positive airway pressure, CPAP) at the time of enrollment
- Life expectancy less than 6 months
- Unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated
- Active respiratory illness, or other acute infection
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: SynagisPalivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV. | Drug | Children at High Risk of severe RSV Infection |
Primary outcome
Percentage of Participants With RSV Hospitalization
Time frame: Approximately 6 months
An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).
7 secondary outcomes
Total Number of RSV-Hospitalization Days
Time frame: Approximately 6 months
Percentage of Participants Who Received Supplemental Oxygen While Hospitalized
Time frame: Approximately 6 months
Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement
Time frame: Approximately 6 months
Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization
Time frame: Approximately 6 months
Total Days of RSV-ICU Stay
Time frame: Approximately 6 months
Percentage of Participants Who Received Mechanical Ventilation
Time frame: Approximately 6 months
Total Days of Mechanical Ventilation During RSV-hospitalization
Time frame: Approximately 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- 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.
Joaquin Valdes study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palivizumab in people with Respiratory Syncytial Virus (RSV), run by AbbVie.
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 4 inclusion and 5 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 13 Mar 2018). 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?
Percentage of Participants With RSV Hospitalization (time frame: Approximately 6 months). 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 13 Mar 2018.