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

NCT01466062 | Completed Phase 3 Results

• 1 other identifier: M12-420
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 6

Brief Summary

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

Keywords

Immunocompromised medical conditions; Respiratory Syncytial Virus Infection; Infant; Newborn; Young children

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 1 (Screening), Day 31, Day 121

Secondary Outcomes (17)

• Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (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.

• Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (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 Hospitalization Caused by Respiratory Syncytial Virus (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

  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

  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.

Study Arms (1)

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.

Drug: Palivizumab

Interventions

Palivizumab DRUG

Also known as: ABT-315, Synagis

Palivizumab

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (6)

Site Reference ID/Investigator# 56847

Hyōgo, Japan

Location

Site Reference ID/Investigator# 56845

Shimotsuke, Japan

Location

Site Reference ID/Investigator# 56842

Tokyo, Japan

Location

Site Reference ID/Investigator# 56844

Tokyo, Japan

Location

Site Reference ID/Investigator# 56846

Tokyo, Japan

Location

Site Reference ID/Investigator# 56843

Yokohama, Japan

Location

Related Links

• Related info

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Palivizumab

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Shigeki Hashimoto, PhD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: November 7, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 17, 2013
• Results First Posted: June 17, 2013

Record last verified: 2013-06

Locations

JP (6)