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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00109187
First received: April 26, 2005
Last updated: June 19, 2013
Last verified: June 2013
  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 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension Study II of Xolair (Omalizumab) in Moderate to Severe, Persistent Asthma Subjects Who Completed Study Q2143g (ALTO)

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Estimated Enrollment: 0
Study Start Date: June 2002
Study Completion Date: April 2003
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00109187     History of Changes
Other Study ID Numbers: Q2461g
Study First Received: April 26, 2005
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Moderate Persistent Asthma
Severe Persistent Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014