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

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Xolair (omalizumab)	Phase III

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Omalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

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

Further study details as provided by Genentech:

Estimated Enrollment:

0

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Study Results This link exits the ClinicalTrials.gov site

Study ID Numbers:	Q2461g
First Received:	April 26, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00109187
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Moderate Persistent Asthma

Severe Persistent Asthma

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Asthma

Omalizumab

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents

Immune System Diseases

Bronchial Diseases

Therapeutic Uses

Anti-Asthmatic Agents

Anti-Allergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00109187