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

NCT ID: NCT00109187

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2003-04-30

Brief Summary

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.

Conditions

Asthma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Xolair (omalizumab)

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Q2461g

Identifier Type: -

Identifier Source: org_study_id