A Phase 3 Randomized Double Blind Placebo Controlled Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis Heterozygous for the F508del CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)
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- STATUS
- Not Recruiting
Summary
The purpose of this study is to evaluate the safety and efficacy of VX-661 in combination with ivacaftor through week 12 in subjects with cystic fibrosis who are heterozygous for the f508del mutation on the CF transmembrane conductance regulator gene and with a second CTFR mutation that is not likely to respond to VX-661 and/or ivacaftor therapy.
Description
The purpose of this study is to evaluate the safety and efficacy of VX-661 in combination with ivacaftor through week 12 in subjects with cystic fibrosis who are heterozygous for the f508del mutation on the CF transmembrane conductance regulator gene and with a second CTFR mutation that is not likely to respond to VX-661 and/or ivacaftor therapy.
Details
| Condition | cystic fibrosis |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX5712 |
| Last Modified on | 19 February 2024 |
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