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A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis
Overall Recruitment Status: Enrollment on hold
 
Official Title
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis
 
Region Sponsors
California - Northern
Vertex Pharmaceuticals Incorporated
 
Acronym NCT No.
NCT05444257
 
Study Type Phase
INTERVENTIONAL
Phase III
 
Purpose
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
 
Detailed Description
 
 
 
Inclusion Criteria
  • Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149)
  • or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study
  • Part B: Completed study drug treatment in Part A
  • or had study drug interruption(s) in Part A, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of Part A Key
 
Exclusion Criteria
  • History of drug intolerance in a parent study
  • Pregnant or breast-feeding females at the time of enrollment in Part A Other protocol defined Inclusion/Exclusion criteria may apply.
 
Keywords and/or Specific Medical Conditions
  • Digestive System Diseases
  • Newborn
  • Diseases
  • Pancreatic Diseases
  • Fibrosis
  • Pathologic Processes
  • Genetic Diseases
  • Respiratory Tract Diseases
  • Inborn
  • Cystic Fibrosis
  • Infant
  • Genetics
  • Lung Diseases
  • Pulmonary Disease
 
KP Clinical Facility
  • Oakland Medical Center
 
Clinical Area
  • Genetics
  • Pulmonary Disease


Principal Investigator:
Bryon Quick
Contact Information:
- CTP Collaborate Team
-CTPCollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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