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Enrollment on hold

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

NCT No.: NCT05444257

Study Type: INTERVENTIONAL

Phase: Phase III

Region: California - Northern

Acronym: 

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

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

Sex

Male & Female

Age Limit

Eligibility Criteria

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
  • Diseases
  • Fibrosis
  • Genetic Diseases
  • Inborn
  • Infant
  • Lung Diseases
  • Newborn
  • Pancreatic Diseases
  • Pathologic Processes
  • Respiratory Tract Diseases
  • Cystic Fibrosis
  • Genetics
  • Pulmonary Disease

Sponsors

  • Vertex Pharmaceuticals Incorporated

KP Clinical Facility

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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