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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: 22 February 2021
Main ID:  NCT04294043
Date of registration: 01/03/2020
Prospective Registration: Yes
Primary sponsor: Chris Goss
Public title: IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) ABATE
Scientific title: A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study)
Date of first enrolment: February 1, 2021
Target sample size: 40
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04294043
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Lauren Braam, MIH
Address: 
Telephone: 206-884-1487
Email: lauren.braam@seattlechildrens.org
Affiliation: 
Name:     Christopher H. Goss, MD, MSc
Address: 
Telephone:
Email:
Affiliation:  University of Washington, Seattle Children's Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written informed consent obtained from subject or subject's legal representative

2. Be willing and able to adhere to the study visit schedule and other protocol
requirements

3. Greater than or equal to 18 years of age at Visit 1

4. 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 milliequivalent (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)

5. Documentation of NTM culture positive defined as follows:

- The two most recent consecutive sputum (or bronchoalveolar lavage (BAL)) cultures
were positive for M. avium complex and/or M. abscessus complex (cultures must be
at least 4 weeks apart)

- The two most recent consecutive cultures are of the same species or subspecies

- The most recent positive culture result is within 4 months prior to screening AND
the two most recent cultures are within 12 months prior to screening

6. Current NTM species or subspecies has never been treated or previous treatment was
associated with clearance of NTM and completed > 2 years prior to Day 1

7. Forced expiratory volume in 1 second (FEV1) = 25 % of predicted value at Screening

8. Able to expectorate sputum

9. Clinically stable with no significant changes in health status within 7 days prior to
Day 1

10. Enrolled in the CFF Cystic Fibrosis Foundation Patient Registry (CFFPR)

11. Willing to discontinue chronic azithromycin use for the duration of the study

Exclusion Criteria:

1. Any of the following abnormal lab values at screening:

- Hemoglobin <10g/dL

- Platelets <100,000/mm3

- White blood cells (WBC) < 4,500/mm3

- Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl
transferase (GGT), or alkaline phosphatase (ALP) =3 x upper limit of normal

- Serum creatinine > 2.0 mg/dl and =1.5 x upper limit of normal

- Ionized calcium = lower limit of normal (only performed if total calcium is =
lower limit of normal)

2. History of solid organ or hematological transplantation

3. Use of bisphosphonates within 7 days prior to Day 1

4. Known sensitivity to gallium

5. Use of any investigational drug and/or participated in any interventional clinical
trial within 28 days prior to Day 1

6. In the opinion of the Investigator, features of active NTM disease are present (e.g.,
clinical worsening is likely due to NTM disease despite definitive treatment of
co-pathogens and/or acute exacerbations)

7. Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months

8. Current diagnosis of osteoporosis

9. For people of childbearing potential:

- Positive pregnancy test at Visit 1 or

- Lactating or

- Unwilling to practice a medically acceptable form of contraception (acceptable
forms of contraception: abstinence, hormonal birth control, intrauterine device,
or barrier method plus a spermicidal agent), unless surgically sterilized or
postmenopausal during the study

10. For people able to father a child: unwilling to use adequate contraception (as
determined by the investigator) during the study

11. Has any other condition that, in the opinion of the Site Investigator/designee, would
preclude informed consent or assent, make study participation unsafe, complicate
interpretation of study outcome data, or otherwise interfere with achieving the study
objectives

12. New initiation of chronic therapy (greater than 21 days) within 28 days prior to the
Enrollment Visit



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Nontuberculous Mycobacterium Infection
Intervention(s)
Drug: Gallium nitrate
Primary Outcome(s)
Adverse Events of Special Interest [Time Frame: Baseline to Day 57]
Secondary Outcome(s)
Clinically significant abnormal laboratory measures. (safety) [Time Frame: Baseline to Day 57]
NTM clearance (efficacy) [Time Frame: Day 6 to Day 111]
Secondary ID(s)
ABATE-IP-18
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Cystic Fibrosis Foundation
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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