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A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)

NCT02354859 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2019-03-21

Study results available
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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

Conditions

Interventions

DRUG

Gallium nitrate

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

DRUG

Normal Saline

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

Sponsors & Collaborators

Principal Investigators

  • Christopher H Goss, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-02-01
Completion
2018-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02354859 on ClinicalTrials.gov