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Completed

NCT Number: NCT01328886

Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children

The purpose of this extension study is to assess the long-term safety and tolerability of omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with inadequately controlled allergic asthma despite current recommended treatment by providing continued treatment with omalizumab to patients who have previously completed the core study.

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Key information

Conditions

Allergic Asthma

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Ohbu, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who completed the core study (IGE025B1301) and who in the investigator's clinical judgment could benefit from continuous treatment of the study drug.

Exclusion criteria

  • Patients who currently have diagnosed cancer, are currently being investigated for possible cancer or have any history of cancer.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means; using a highly effective method of birth control; or agreeing on total abstinence and the investigator also judges that the age, career lifestyle or sexual orientation of the patient ensures compliance.
  • With clinically significant uncontrolled systemic disease (eg: infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, cerebro-vascular, endocrinologic or gastrointestinal disease) after the treatment period of the core study.
  • Patients with a history of major protocol violations during the core study and who are considered potentially unreliable as judged by the investigator at each site.

Treatment and study plan

Omalizumab

Drug

omalizumab lyophilized 150 mg injection

Primary outcomes

  1. To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs

    Time frame: Every 3 months for approximately 2 years

Secondary outcomes

  1. To explore the efficacy of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC)

    Time frame: Every 3 months for approximately 2 years

  2. To explore the efficacy of omalizumab by QOL questionnaire score (Quality of life questionnaires for pediatric patients with bronchial asthma and their parents or caregivers (Gifu))

    Time frame: Every 3 months for approximately 2 years

  3. To explore the efficacy of omalizumab by use of asthma long-term control medications

    Time frame: Every 3 months for approximately 2 years

  4. To explore the efficacy of omalizumab by Pulmonary function (FEV1, FVC, V(・)50, V(・)25 and FEF25-75%)

    Time frame: Every 3 months for approximately 2 years

  5. To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma

    Time frame: Every 3 months for approximately 2 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite Current Recommended Treatment

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2011
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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