CFF - Study of N6022in People with CF who have two copies of the F508del-CFTR mutation

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Clinical Research Information Sheet

Study Name:

Study of N6022in People with CF who have two copies of the F508del-CFTR mutation

Study Type:

Interventional

Intervention Category:

Other

Study Sponsor:

N30 Pharma

Study Phase:

Recruitment Status:

Recruiting

Study Drug(s):

N6022 (N30)

Number of Participants Being Recruited:

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

This trial is designed to evaluate the safety, tolerability, pharmacokinetics, and effects on CFTR biomarkers of N6022 injected once daily for 7 days in adult cystic fibrosis subjects who are homozygous for the F508del-CFTR mutation. Increasing doses of N6022 will be administered sequentially until a maximum tolerated dose has been reached. Specimens of blood, urine, stool will be taken throughout the study along with lung functioning testing and other tests. Study participants will have ten study visits including an inpatient hospital stay. The length of study participation is 45 days.

ELIGIBILITY

Age:	>= 18 Years
FEV1:	>= 40 Percent Predicted
P. aeruginosa status:	Not applicable
B. cepacia status:	Not applicable
Other Primary Eligibility Requirements: Eligible subjects must be homozygous for the delta F508 mutation.
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.

FOR MORE INFORMATION:

Sponsor Contact Information:

Trial Specific Link on ClinicalTrials.gov:

http://clinicaltrials.gov/show/NCT01746784

Clinical Research Terms Glossary:

Click here

PARTICIPATING SITES:

The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.

The Children's Hospital/University of Alabama at Birmingham (Pediatric), Birmingham, AL, 35233
Contact Information:
    Hathorne, Heather
    Phone: (205) 638-9568
    Email: hhathorne@peds.uab.edu

Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
Contact Information:
    Pardee, Churee
    Phone: (720) 777-6162
    Email: chureeporn.pardee@childrenscolorado.org
National Jewish Health (Adult), Denver, CO, 80206
Contact Information:
    Jones, Marion
    Phone: (303) 398-1265
    Email: jonesm@njhealth.org

Northwestern University (Adult), Chicago, IL, 60611
Contact Information:
    Singh, Noopur
    Phone: (312) 227-6861
    Email: nosingh@luriechildrens.org

Children's Hospital Boston (Pediatric), Boston, MA, 02115
Contact Information:
McGeachey, Amanda
Email: amanda.mcgeachey@childrens.harvard.edu

Johns Hopkins University (Pediatric), Baltimore, MD, 21287
Contact Information:
    Callahan, Karen
    Phone: (443) 287-8983
    Email: kcallah1@jhmi.edu

The Minnesota Cystic Fibrosis Center (Pediatric), Minneapolis, MN, 55455
Contact Information:
    Grover, Patricia
    Phone: (612) 626-7425
    Email: Grove026@umn.edu

St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
    Rodgers, Denise
    Phone: (314) 286-1176
    Email: rodgers@kids.wustl.edu
St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
    Burks, Patricia
    Phone: (314) 454-5175
    Email: Burks_P@kids.wustl.edu

University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
Contact Information:
    Stephenson, Kelly
    Phone: (919) 843-7121
    Email: kelly.stephenson@unc.edu

University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
Contact Information:
    Ksenich, Roberta (Bobbi)
    Phone: (216) 844-5733
    Email: Roberta.Ksenich@UHHospitals.org
Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
Contact Information:
    Johnson, Mary Terri
    Phone: (614) 722-4766
    Email: Terri.Johnson@nationwidechildrens.org

Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
Contact Information:
    Hartigan, Elizabeth
    Phone: (412) 692-7060
    Email: elizabeth.hartigan@chp.edu