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NCT01701583 · ClinicalTrials.gov registry record · Phase 4

Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria

A Phase 4 study, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 4
Development phase
10
Enrollment target

NCT01701583: Completed Phase 4 study, sponsored by University of Colorado, Denver.

NCT01701583 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01701583, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 4
Development phase
10 participants
Enrollment target

Study Summary

This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

Primary Outcome

In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.

Interventions

  • DRUG Omalizumab

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2013-04
Est. Completion 2017-10
Phase Phase 4
University of Colorado, Denver

1,283 total trials

What the finished NCT01701583 record still lists

NCT01701583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Omalizumab is the first listed.

NCT01701583 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01701583 about?

NCT01701583 is a clinical study titled "Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria". This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

What is the current status of trial NCT01701583?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2013-04. Estimated completion is 2017-10.

What interventions are being tested in trial NCT01701583?

The interventions under investigation include: Omalizumab (DRUG).

Who is sponsoring clinical trial NCT01701583?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01701583's enrollment target sits among peer trials

10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01701583, the US trial registry maintained by the National Library of Medicine. NCT01701583 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.