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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 (Synagis Russia)

Primary Purpose

Respiratory Syncytial Virus (RSV)

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Palivizumab

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus (RSV) focused on measuring Bronchopulmonary dysplasia (BPD), RSV hospitalization, Palivizumab, Immunoprophylaxis, Chronic lung disease (CLD) of prematurity

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria (main exclusion criteria):

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children at High Risk of severe RSV Infection

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Total Number of RSV-Hospitalization Days

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.

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.

Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization

Total Days of RSV-ICU Stay

Percentage of Participants Who Received Mechanical Ventilation

Total Days of Mechanical Ventilation During RSV-hospitalization

Full Information

NCT ID

NCT02968173

First Posted

November 16, 2016

Last Updated

February 9, 2018

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02968173

Brief Title

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

Acronym

Synagis Russia

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

November 9, 2016 (Actual)

Primary Completion Date

July 13, 2017 (Actual)

Study Completion Date

July 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Syncytial Virus (RSV)

Keywords

Bronchopulmonary dysplasia (BPD), RSV hospitalization, Palivizumab, Immunoprophylaxis, Chronic lung disease (CLD) of prematurity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Children at High Risk of severe RSV Infection

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Palivizumab

Other Intervention Name(s)

Synagis

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of Participants With RSV Hospitalization

Description

Time Frame

Approximately 6 months

Secondary Outcome Measure Information:

Title

Total Number of RSV-Hospitalization Days

Time Frame

Approximately 6 months

Title

Percentage of Participants Who Received Supplemental Oxygen While Hospitalized

Description

Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.

Time Frame

Approximately 6 months

Title

Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement

Description

Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.

Time Frame

Approximately 6 months

Title

Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization

Time Frame

Approximately 6 months

Title

Total Days of RSV-ICU Stay

Time Frame

Approximately 6 months

Title

Percentage of Participants Who Received Mechanical Ventilation

Time Frame

Approximately 6 months

Title

Total Days of Mechanical Ventilation During RSV-hospitalization

Time Frame

Approximately 6 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria (main exclusion criteria): 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joaquin Valdes

Organizational Affiliation

AbbVie

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Description

Related Info

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