NCT01863238 - An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions

Cystic Fibrosis

Interventions

OTHER

Ophthalmologic examinations

Subjects will undergo an ophthalmologic examination at study entry (Day 1) and every 6 months thereafter for 2 years (Months 6, 12, 18, and 24). Subjects who discontinue treatment with commercially-available ivacaftor for any reason and are willing to continue participation in the study will complete the study.

DRUG

Ivacaftor Exposed

Trial Locations (38)

Unknown

Birmingham

Tucson

Long Beach

Aurora

Wilmington

St. Petersburg

Boise

Chicago

Indianapolis

Kansas City

Louisville

Portland

Boston

Ann Arbor

Detroit

Minneapolis

Columbia

Kansas City

Omaha

Rochester

Akron

Cincinnati

Toledo

Oklahoma City

Portland

Philadelphia

Pittsburgh

Providence

Charleston

Knoxville

Nashville

Fort Worth

Houston

Salt Lake City

Charlottesville

Seattle

Spokane

Morgantown

All Listed Sponsors

collaborator

Cystic Fibrosis Foundation

OTHER

lead

Vertex Pharmaceuticals Incorporated

INDUSTRY