NCT02544451 - Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor | Biotech Hunter

Enrollment

246

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

August 31, 2018

Study Completion Date

April 30, 2020

Conditions

Cystic Fibrosis

Interventions

DRUG

LUM/IVA

"Lumacaftor (LUM) 200 mg every 12 hours (q12h)/ivacaftor (IVA) 250 mg q12h (for 6 through 11 years of age).~LUM 400 mg q12h/IVA 250 mg q12h (for 12 years and older)."

DRUG

LUM/IVA

LUM 200 mg q12h/IVA 250 mg q12h (for 6 through 11 years of age).

Trial Locations (60)

Unknown

Birmingham

Tucson

Long Beach

Palo Alto

Aurora

Wilmington

Jacksonville

Orlando

Atlanta

Chicago

Indianapolis

Iowa City

Boston

Minneapolis

Kansas City

St Louis

Omaha

Lebanon

Buffalo

Syracuse

Chapel Hill

Cincinnati

Cleveland

Dayton

Portland

Pittsburgh

Charleston

Austin

Houston

Salt Lake City

Colchester

Charlottesville

Norfolk

Richmond

Seattle

Madison

Milwaukee

Parkville

Herston

New Lambton Heights

Subiaco

Westmead

Brussels

Leuven

Vancouver

Toronto

Montreal

Copenhagen

Bron

Bordeaux

Paris

Berlin

Cologne

Giessen

Hanover

Stockholm

Leeds

Belfast

Edinburgh

London

All Listed Sponsors

lead

Vertex Pharmaceuticals Incorporated

INDUSTRY