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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01093521
Date of registration: 24/03/2010
Prospective Registration: Yes
Primary sponsor: University of Washington
Public title: A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
Scientific title: A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
Date of first enrolment: April 2010
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01093521
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Christopher H Goss, MD, MSc
Address: 
Telephone:
Email:
Affiliation:  University of Washington
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adult male or female, between 18 and 55 years of age

2. Documented chronic colonization with Pseudomonas Aeruginosa (Pa)

3. Confirmed diagnosis of CF:

1. Documented history of > 60 mmol/L chloride concentration in pilocarpine sweat
chloride test And/Or

2. Genotype with two identifiable mutations consistent with CF, accompanied by one
or more phenotypic features consistent with diagnosis of CF

4. Forced expiratory volume in the first second (FEV1) = 30% of predicted value

5. Able to expectorate sputum

6. Serum liver function tests = 2.5 x upper limit of normal

7. Serum urea nitrogen (BUN) and creatinine = 1.5 x upper limit of normal

8. Serum creatinine = 2.0 mg/dl

9. Hemoglobin = 9 g/dl, platelets = 100,000/mm3, and white blood cells (WBC) = 4,500/mm3
and = 15,000/mm3

10. Ionized calcium = the lower limit of normal

11. Able to understand and sign the informed consent document, communicate with the
Investigator, and comply with the requirements of the protocol

12. If female and of childbearing potential, must have a negative pregnancy test on Day 1
prior to receiving study drug

13. If female and of childbearing potential, is willing to use adequate contraception, as
determined by the investigator, for the duration of the study

Exclusion Criteria:

1. Acute pulmonary exacerbation requiring antibiotic intervention within 2 weeks prior to
screening

2. Osteoporosis defined as the most recent dexa scan within the prior 5 years with a
T-score = -2.5

3. Pregnant or lactating female

4. Known sensitivity to gallium

5. Use of biphosphonates

6. Use of any investigational drug and/or participated in any clinical trial within 3
months prior to screening



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Intervention(s)
Drug: 100 mg/m2 dose
Drug: 200 mg/m2 dose
Primary Outcome(s)
Number of Events When Study Drug Infusion Was Stopped Early [Time Frame: 6 days from starting dose]
Number of Serious Adverse Events [Time Frame: 56 days from starting dose]
Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV GaniteĀ®) [Time Frame: Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28]
Secondary Outcome(s)
Change in Lung Function From Baseline to Day 15 [Time Frame: 15 days from starting dose]
Change in P. Aeruginosa Density From Baseline to Day 56 [Time Frame: 56 days from starting dose]
Change in P. Aeruginosa Density From Baseline to Day 8 [Time Frame: 8 days from starting dose]
Change in Spirometry as Measured by FVC From Baseline to Day 8 [Time Frame: 8 days from starting dose]
Change in Spirometry From Baseline to Day 28 [Time Frame: 28 days from starting dose]
Change in Spirometry From Baseline to Day 56 [Time Frame: 56 days from starting dose]
Change in Spirometry From Baseline to Day 8 [Time Frame: 8 days]
Change in Sputum P. Aeruginosa Density From Baseline to Day 15 [Time Frame: 15 days from starting dose]
Secondary ID(s)
35876
US FDA 5R01FD003704
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Cystic Fibrosis Foundation
Ethics review
Results
Results available: Yes
Date Posted: 12/01/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01093521
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