A Study Evaluating the Long-term Safety and Effectiveness of Experimental VX-445 Combination Therapy for Cystic Fibrosis (CF)

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Age: 12 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: cystic fibrosis, F508del Mutation, genetic mutation
Type: Drug study, Phase 3
Target:
5 Participants
Investigator:
Description
The purpose of this research study is to learn more about the safety and effectiveness of VX-445. It will be used in combination with TEZ and IVA in patients with cystic fibrosis (CF).

· The triple combination VX-445/TEZ/IVA is an experimental drug. “Experimental” means the drug is not approved by the FDA. It is still being tested for safety and effectiveness.

· TEZ in combination with IVA (TEZ/IVA) is approved in certain countries for use in some people living with CF who are 12 years or older.

· IVA is approved in a number of countries globally, for use in some people living with CF as young as 2 years old.

If you would like to know in which countries or for which people living with CF TEZ/IVA or IVA has been approved, please ask your Study Doctor.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Completed study drug treatment in a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.

Exclusion criteria:

  • History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
  • Current participation in an investigational drug trial (other than a parent study) Other protocol defined Inclusion/Exclusion criteria may apply.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will be compensated for your participation in this study. The study team will provide you with an outline of the compensation amount for each visit. In addition, you will be reimbursed for actual out of pocket expenses. There are 13 in-clinic study visits, and 14 other occasions on which telephone contact will occur. If you complete these, you will get a total of $1,410.00. If you miss any of the visits, you will not be compensated for those visits. If you terminate the study early, you will receive an amount based on the visits that you have completed.
Resources
Schedule
Study duration and period
If you agree, you will be in this study for about 100 weeks. You will need to visit the research site about 12 times along with 14 phone calls occurring roughly once a month. The treatment period will last approximately 96 weeks. The safety follow-up period will last approximately 4 weeks after the last dose of Study Drug.
Recruitment period
From Feb. 20, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Brandt Robinson
Research Topic
Conditions:
  • Cystic Fibrosis