91大神

Clinical Trial</h3>\r\n<p><strong>Offered by:</strong> 91大神&nbsp;Children's<br>\r\n<strong>Location:</strong> Orlando</p>\r\n<h3>Trial Name</h3>\r\n<p>A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy &amp; Safety of VX-445 (16 weeks)</p>\r\n<h3>What is the trial about?</h3>\r\n<p>The purpose of the study is to learn more about the effectiveness and safety of VX-445 used in combination with TEZ (tezacaftor) and IVA (ivacaftor) in patients with cystic fibrosis who have two F508 deletions (F/F).</p>\r\n<h3>Who can participate?</h3>\r\n<p>Individuals, 12 years of age or older, who have a confirmed diagnosis of Cystic Fibrosis and have two F508 deletions (F/F).</p>\r\n<h3>What is involved?</h3>\r\n<p>Participation could last approximately 16 weeks. This includes a screening period that will last up to four weeks, four-week run-in period, four-week treatment period and a follow-up four weeks after the last dose of the study drug.</p>\r\n<p>There will be up to seven clinic visits, including:</p>\r\n<ul>\r\n<li><strong>Blood draws:</strong> The total amount of blood that will be taken during this study will be about 137mL (about 28 teaspoons). Total of six scheduled blood draws.</li>\r\n<li><strong>ECGs:</strong> Total of six scheduled ECGs.</li>\r\n<li><strong>Spirometry (PFT):</strong> Total of six scheduled PFTs.</li>\r\n<li><strong>Sweat Chloride Tests:</strong> Total of five sweat chloride tests.</li>\r\n<li><strong>Eye Exam:</strong> One eye exam.</li>\r\n</ul>\r\n"}} id=text-a34ad5487a class=cmp-text>

Clinical Trial

Offered by: 91大神听Children's
Location: Orlando

Trial Name

A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy & Safety of VX-445 (16 weeks)

What is the trial about?

The purpose of the study is to learn more about the effectiveness and safety of VX-445 used in combination with TEZ (tezacaftor) and IVA (ivacaftor) in patients with cystic fibrosis who have two F508 deletions (F/F).

Who can participate?

Individuals, 12 years of age or older, who have a confirmed diagnosis of Cystic Fibrosis and have two F508 deletions (F/F).

What is involved?

Participation could last approximately 16 weeks. This includes a screening period that will last up to four weeks, four-week run-in period, four-week treatment period and a follow-up four weeks after the last dose of the study drug.

There will be up to seven clinic visits, including:

• Blood draws: The total amount of blood that will be taken during this study will be about 137mL (about 28 teaspoons). Total of six scheduled blood draws.
• ECGs: Total of six scheduled ECGs.
• Spirometry (PFT): Total of six scheduled PFTs.
• Sweat Chloride Tests: Total of five sweat chloride tests.
• Eye Exam: One eye exam.

<strong>Trial Name:&nbsp;</strong>A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of VX-445</p>\r\n<p><strong>IRB#</strong> 1246533</p>\r\n"}} id=text-cb952b34fd class=cmp-text>

Trial Name:听A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of VX-445

IRB# 1246533