CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 806 enrolled
Drug / intervention
Omalizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01922037
NCT01922037Phase 4Completed
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A Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab

Hoffmann-La Roche·interventional·Posted Aug 14, 2013·Updated Dec 11, 2017

In Brief

A Phase 4 clinical trial evaluating Omalizumab for Asthma. Completed, enrolled 806 participants across 145 sites.

Detailed Summary

This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 14, 2013
Enrollment StartJun 19, 2013
Primary CompletionMar 31, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.9 years ago

Interventions

Omalizumabdrug

Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.