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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354859
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Chris Goss, University of Washington

Brief 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


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Gallium nitrate Drug: Normal Saline Phase 2

Detailed Description:
This is a phase 2, multi-center, randomized, placebo-controlled trial in adults with CF chronically infected with P. aeruginosa. The study will evaluate the safety and clinical efficacy of a five day infusion of IV gallium nitrate (IV gallium). 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018


Arm Intervention/treatment
Active Comparator: 5 day of infusion of gallium nitrate
Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days.
Drug: Gallium nitrate
Study subjects will receive an infusion of either placebo or gallium nitrate.
Other Name: Ga, GaN3O9

Placebo Comparator: 5 day of infusion of normal saline
Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga
Drug: Normal Saline
Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Other Name: Sodium Chloride, NS




Primary Outcome Measures :
  1. Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28 [ Time Frame: Baseline to Day 28 ]
    Difference between treatment groups in the proportion of subjects with 5% or greater relative change in FEV1 (liters) from baseline to Day 28.


Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 to Day 56 ]
    Incidence is defined as the number and percentage of participants with at least one event over the 56 day follow-up period.

  2. Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 to Day 56 ]
    Rate is defined as the number of events per participant follow-up week.

  3. Relative Change in FEV1 (Liters) From Baseline to Day 56 [ Time Frame: Day 1 to Day 56 ]
    Difference between treatment groups in the relative change in FEV1 (liters) from Baseline to Day 56

  4. Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56 [ Time Frame: Day 1 to Day 56 ]
    Difference between treatment groups in the absolute change in P. aeruginosa sputum density (log10 (CFU)) from Baseline to Day 56 based on quantitative cultures.

  5. Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), From Baseline to Day 56 [ Time Frame: Day 1 to Day 56 ]
    Difference between treatment groups in the absolute change in respiratory symptoms, as measured by the the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from Baseline to Day 56. The Cystic Fibrosis Respiratory Symptoms Daily Diary asks a participant to state the extent of their 8 respiratory symptoms : difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
    2. two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
    3. 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

Exclusion criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354859


Locations
Show Show 23 study locations
Sponsors and Collaborators
University of Washington
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Christopher H Goss, MD University of Washington
  Study Documents (Full-Text)

Documents provided by Chris Goss, University of Washington:
Statistical Analysis Plan  [PDF] October 6, 2016
Study Protocol  [PDF] August 28, 2014

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Responsible Party: Chris Goss, Professor, Medicine/Pulmonary & Critical Care Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02354859    
Other Study ID Numbers: STUDY00002609
2R01FD003704-03A1 ( U.S. FDA Grant/Contract )
First Posted: February 3, 2015    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once the study is complete and the primary paper is published, de-identified data will be available from the Cystic Fibrosis Therapeutics Development Network Coordinating Center upon approval of a formal data request.
Keywords provided by Chris Goss, University of Washington:
Cystic Fibrosis
Gallium Nitrate
IV Gallium
Pseudomonas aeruginosa
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gallium nitrate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antineoplastic Agents