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Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

NCT01976208 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 630

Last updated 2015-12-22

No results posted yet for this study

Summary

The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma.

Conditions

  • Allergic Asthma

Interventions

DRUG

Omalizumab

The recommended dose is 0.016mg/kg/IgE(IU/ml) every 4 weeks. It is administered by subcutaneous injection.If the total dose per 4 weeks is 150\~300mg, the dosing interval will be every 4 weeks; if the total dose per 4 weeks is 450mg\~750mg，then dosing interval is every 2 weeks.

DRUG

placebo

Sponsors & Collaborators

  • Shanghai Zhangjiang Biotechnology Limited Company

    lead INDUSTRY

Principal Investigators

  • Nanshan Zhong, M.D. · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976208 on ClinicalTrials.gov