Skip to main content
OpenTrials
Completed

NCT Number: NCT00109187

An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g

This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Successful completion of the 24-week study period in Study Q2143g
  • Signed informed consent (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
  • For subjects who have never received Xolair, a serum IgE level >=30 IU/mL and <=1300 IU/mL and have a body weight >=20 kg and <=150 kg
  • Females of childbearing potential must, in the opinion of the investigator, be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.

Exclusion criteria

  • Thrombocytopenia as evidenced by a platelet count of <100,000/uL
  • Pregnant or breastfeeding
  • Significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrine or gastrointestinal disease) within the previous 3 months
  • History of neoplasia
  • Any systemic condition requiring regular administration of an immunoglobulin
  • Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
  • History of noncompliance with medical regimens
  • Current participation in a study using an investigational new drug other than Xolair
  • Participation in Study Q2195g

Treatment and study plan

Xolair (omalizumab)

Drug

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

Open-Label Extension Study II of Xolair (Omalizumab) in Moderate to Severe, Persistent Asthma Subjects Who Completed Study Q2143g (ALTO)

Important dates

Study start
2002
Study completion
2003
First posted
Apr 26, 2005
Registry last updated
Jun 21, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.