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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02968173
• Date of registration: 16/11/2016
• Prospective Registration: No
• Primary sponsor: AbbVie
• Public 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 Synagis Russia
• Scientific 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
• Date of first enrolment: November 9, 2016
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02968173
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belarus, Russian Federation

Contacts

• Name: Joaquin Valdes
• Affiliation: AbbVie

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 24 Months
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Syncytial Virus (RSV)

Intervention(s)

Drug: Palivizumab

Primary Outcome(s)

Percentage of Participants With RSV Hospitalization [Time Frame: Approximately 6 months]

Secondary Outcome(s)

Percentage of Participants Who Received Mechanical Ventilation [Time Frame: Approximately 6 months]

Percentage of Participants Who Received Supplemental Oxygen While Hospitalized [Time Frame: Approximately 6 months]

Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization [Time Frame: Approximately 6 months]

Total Days of Mechanical Ventilation During RSV-hospitalization [Time Frame: Approximately 6 months]

Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement [Time Frame: Approximately 6 months]

Total Days of RSV-ICU Stay [Time Frame: Approximately 6 months]

Total Number of RSV-Hospitalization Days [Time Frame: Approximately 6 months]

Secondary ID(s)

M15-539

2016-000221-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02968173