Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278314
Expanded Access Status : Approved for marketing
First Posted : September 11, 2017
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Tracking Information
First Submitted Date September 6, 2017
First Posted Date September 11, 2017
Last Update Posted Date November 2, 2018
 
Descriptive Information
Brief Title Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis
Brief Summary To provide TEZ/IVA combination therapy to CF patients who are 12 years of age and older who completed Vertex TEZ/IVA combination therapy clinical studies (NCT02565914 or NCT03150719). To provide TEZ/IVA combination therapy to CF patients in critical need who are 12 years of age and older, homozygous for F508del.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention Drug: tezacaftor/ivacaftor
orally administered TEZ/IVA combination therapy
Other Name: TEZ/IVA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03278314
Responsible Party Vertex Pharmaceuticals Incorporated
Study Sponsor Vertex Pharmaceuticals Incorporated
Collaborators Not Provided
Investigators Not Provided
PRS Account Vertex Pharmaceuticals Incorporated
Verification Date October 2018