CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 119 enrolled
Drug / intervention
Gallium nitrate +1 moredrug
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/NCT02354859
NCT02354859Phase 2Completed
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A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)

University of Washington·interventional·Posted Feb 3, 2015·Updated Mar 21, 2019

In Brief

A Phase 2 clinical trial evaluating Gallium nitrate and Normal Saline for Cystic Fibrosis. Completed, enrolled 119 participants across 23 sites.

Detailed Summary

The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28. Funding Source - FDA OOPD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
CollaboratorsCystic Fibrosis Foundation

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 3, 2015
Enrollment StartMar 1, 2016
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.4 years ago

Interventions

Gallium nitratedrug

Study subjects will receive an infusion of either placebo or gallium nitrate.

Normal Salinedrug

Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.