Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:2/6/2019
Start Date:August 23, 2018
End Date:September 2020
Contact:Medical Information
Email:medicalinfo@vrtx.com
Phone:617-341-6777

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A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del

This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and
ivacaftor (IVA) in subjects 1 to less than 2 years of age with cystic fibrosis (CF),
homozygous for F508del (F/F).


Key Inclusion Criteria:

- Subjects will be 1 to less than 2 years of age on Day 1 of the relevant part of the
study.

- Homozygous for F508del (F/F).

Key Exclusion Criteria:

- Any clinically significant laboratory abnormalities at the Screening Visit that would
interfere with the study assessments or pose an undue risk for the subject.

- Solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
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801 7th Avenue
Fort Worth, Texas 76104
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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