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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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

Key facts

Study ID

NCT02354859

Run by

University of Washington

People needed

119

Starts

2016-03-01

Expected to finish

2018-02-01

Last updated by the study team

2019-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Greater than or equal to 18 years of age at Screening
• Documented chronic colonization with P. aeruginosa defined as dentification in two sputum or oropharyngeal cultures within the year prior to Day 1
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
• two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
• Abnormal nasal potential difference (NPD; change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
• FEV1 ≥ 25 % of predicted value at Screening
• Able to expectorate sputum
• Serum liver function tests ≤ 2.5 x upper limit of normal at Screening
• Serum urea nitrogen (BUN) ≤ 1.5 x upper limit of normal at Screening
• Serum creatinine ≤ 2.0 mg/dl and ≤ 1.5 x upper limit of normal at Screening
• Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC)
• ≥ 4,500/mm3 at Screening
• Ionized calcium ≥ lower limit of normal at Screening
• Written informed consent obtained from subject or subject's legal representative
• Able to communicate with the Investigator and comply with the requirements of the protocol
• If female and of childbearing potential, must have a negative pregnancy test on Day 1 prior to receiving study drug
• If female and of childbearing potential, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator
• If male and able to father a child, is willing to use adequate contraception for the duration of the study through Visit 5, as determined by the investigator
• Clinically stable with no significant changes in health status within 14 days prior to Day 1

You may not qualify if…

• Use of inhaled antibiotics within seven days prior to Day 1
• Unable or unwilling to withhold use of chronic inhaled antibiotics through Day 28
• Use of intravenous, inhaled, or oral antibiotics for an acute indication within 14 days prior to Day 1
• Use of bisphosphonates within seven days prior to Day 1
• History of osteoporosis (defined as the most recent dexa scan with a T-score ≤ -2.5 with the dexa scan performed within the five years prior to Screening)
• Lactating female
• Known sensitivity to gallium

Where it is running

• AL Adult Birmingham / The Children's Hospital Atlanta — Birmingham, Alabama, United States
• UC San Diego Medical Center — La Jolla, California, United States
• Denver Adult / National Jewish Health — Denver, Colorado, United States
• Shands Hospital — Gainesville, Florida, United States
• Jackson Memorial Hospital; University of Miami Hospital; University of Miami Hospital and Clinics — Miami, Florida, United States
• Atlanta Emory Adult / Emory University Hospital — Atlanta, Georgia, United States
• Chicago Northwestern Adult / Northwestern Memorial Hospital — Chicago, Illinois, United States
• Iowa City University of Iowa Adult / University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Lexington, KY Adult / University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Portland, ME Adult — Portland, Maine, United States
• Baltimore Hopkins Adult / John Hopkins Hospital — Baltimore, Maryland, United States
• Boston CHB Adult / Boston Children's Hospital (BCH) — Boston, Massachusetts, United States
• Minneapolis CC and Adult / University of Minnesota Medical Center, Fairview — Minneapolis, Minnesota, United States
• Omaha Adult / The Nebraska Medical Center — Omaha, Nebraska, United States
• Lebanon, NH Dartmouth-Hitchcock CC and Adult / Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Cleveland CC and Peds, Hospital of Cleveland — Cleveland, Ohio, United States
• Columbus CC and Peds / Nationwide Children's Hospital — Columbus, Ohio, United States
• Toledo, OH CC and Peds / The Toledo Hospital; Toledo Children's Hospital — Toledo, Ohio, United States
• Oklahoma City Adult / Presbyterian Hospital at OU Medical Center — Oklahoma City, Oklahoma, United States
• Pittsburgh Adult, Children's Hospital of Pittsburgh UPMC — Pittsburgh, Pennsylvania, United States
• SC CC and Adult Charleston / MUSC — Charleston, South Carolina, United States
• Salt Lake City Adult, Intermountain Cystic Fibrosis Center — Salt Lake City, Utah, United States
• Seattle UW Adult / University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.