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Restore CFTR Function Closed to Enrollment

Phase 3 study of VX-659 triple combination drug in people with CF 12 years and older who have one copy of the F508del mutation and one copy of a minimal function mutation (VX17-659-102)

This randomized, placebo-controlled study will be taking place at multiple care centers across the U.S. It will evaluate the effectiveness, safety, and effect on the body of the drug VX-659 in combination with tezacaftor and ivacaftor. It is for people with cystic fibrosis ages 12 and older with one copy of the F508del CFTR mutation and one copy of a minimal function mutation. 

 Researchers will assess the effectiveness of the drug VX-659 in combination with tezacaftor and ivacaftor by measuring lung function. Researchers will also monitor for pulmonary exacerbations and measure participants’ body mass index, sweat chloride, and other outcomes. The trial is for people ages 12 and older with cystic fibrosis and one copy of the F508del CFTR mutation and one copy of a minimal function mutation. A minimal function mutation refers to mutations that do not make meaningful protein. A list of the eligible mutations can be found here: https://www.cff.org/PDF-Archive/Study-659-102-protocol-feb-2018/ . This study may require sweat tests, lung function tests, blood draws and/or other measures.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 Years and Older

  • Mutation(s):

    One Copy F508del

  • FEV1% Predicted:

    40 to 90%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    32 weeks

  • Number of Study Visits:

    10

Additional Information

Other Primary Eligibility Criteria

Participants must have one F508del mutation and one minimal function mutation.  Please click on the link in the description above to see the list of eligible mutations.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 Years and Older

  • Mutation(s):

    One Copy F508del

  • FEV1% Predicted:

    40 to 90%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Clinical Studies 101

  • Questions to Ask When Considering a Specific Trial

    Clinical trials that test potential drugs and therapies in people with cystic fibrosis are a major part of CF research. They take place at Cystic Fibrosis Foundation-accredited care centers all over the United States and enroll people with CF of all ages.

  • Patient Safety Is a Priority

    Nothing is more important than patient safety in developing new treatments for cystic fibrosis. The U.S. government requires that all clinical trials are supervised for safety, and the Cystic Fibrosis Foundation adds additional measures to protect study volunteers.

  • How Do Clinical Trials Work

    Each clinical trial has a study sponsor and a protocol. Potential drugs must move through four well-defined phases of testing in patients.

     

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