A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
- Conditions
- Cystic FibrosisMedDRA version: 20.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2018-004652-38-PL
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 458
PART A
Subjects transitioning from Study 659-105 must meet all of the following criteria to be eligible for Part A:
1.Subject (or his or her legally appointed and authorized representative) is willing to sign and date an informed consent form (ICF), and, when appropriate, an assent form.
2.Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
3..Participated in Study 659-105. Current participation is defined as one of the following:
•On study drug treatment in Study 659-105 as of the day prior to the Part A Day 1 Visit in this study.
•On study drug interruption in Study 659-105 as of the day prior to the Part A Day 1 Visit in this study.
Subjects who permanently discontinue VX-659/TEZ/IVA in Study 659-105 for any reason other than enrolling into this study are not eligible.
4.Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation .
Inclusion criteria for subjects resuming participation in Part A of this
study after enrolling in another qualifying Vertex study include all of the criteria above AND the following criteria:
5.Completed the ETT visit in another qualified Vertex study before or on same day as the Returning Visit in this study. If more than 30 days have elapsed since the ETT visit in the other qualified Vertex study, approval of the medical monitor is required.
6.Subjects who depart this study more than once to participate in
another qualified Vertex study may not return to this study a second
time.
PART B
Subjects who meet all of the following criteria will be eligible for Part B:
1.Subject (or his or her legally appointed and authorized representative) is willing to sign and date a Part B informed consent form (ICF), and, when appropriate, an assent form.
2.Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
3.Completed the Week 96 Visit in Part A. Participation is defined as oneof the following:
- On study drug treatment at the end of Part A as of the day prior to the Part B Day 1 Visit in this study.
- On study drug interruption at the end of Part A as of the day prior to the Part B Day 1 Visit in this study.
4.Willing to remain on a stable CF treatment regimen (as defined in
Section 9.5) through completion of study participation.
Inclusion criteria for subjects resuming participation in Part B of this
study after enrolling in another qualifying Vertex study include all of the criteria above AND the following criteria:
5.Completed the ETT visit in another qualified Vertex study before or on same day as the Returning Visit in this study. If more than 30 days have elapsed since the ETT visit in the other qualified Vertex study, approval of the medical monitor is required.
6.Subjects who depart this study more than once to participate in
another qualified Vertex study may not return to this study a second
time.
Are the trial subjects under 18? yes
Number of subjects for this age range: 83
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 375
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
PART A
Subjects who meet any of the following criteria will NOT be eligible for Part A:
1.History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
2.Pregnant and nursing females. All female subjects must have a negative pregnancy test at the Part A Day 1 Visit before receiving the first dose of study drug.
3.History of drug intolerance in Study 659-105 that would pose an additional risk to the subject in the opinion of the investigator (e.g., subjects with a history of allergy or hypersensitivity to VX-659/TEZ/IVA).
4.Current participation in an investigational drug trial (other than Study 659 105). Participation in a non-interventional study (including observational studies, registry studies, and studies requiring blood collections without administration of study drug) and screening for another Vertex study is permitted.
Subjects resuming participation in Part A of this study after enrolling in another qualifying Vertex study must not meet Part A Exclusion Criteria 1 through 3, and also must not meet any of the following criteria:
5.Pregnant and nursing females. All female subjects must have a
negative pregnancy test at the Returning Visit before receiving the first dose of study drug.
6.History of drug intolerance in another qualified Vertex study that
would pose an additional risk to the subject in the opinion of the
investigator. If protocol-defined interruption criteria is met in another
qualified Vertex study, then the subject must remain on study drug
interruption until the subject meets criteria in Section 9.8 and receives approval by the medical monitor to resume study drug dosing in this study.
7.Has received the first dose of study drug in the Treatment Period of
another qualified Vertex study.
8.Has access to commercially available or managed-access-program
supplied VX-445/TEZ/IVA.
PART B
Subjects who meet any of the following criteria will NOT be eligible for this study:
1.History of any comorbidity that, in the opinion of the investigator,
might confound the results of the study or pose an additional risk in
administering study drug to the subject.
2.Pregnant and nursing females. All female subjects must have a
negative pregnancy test at the Part B Day 1 Visit before receiving the
first dose of study drug.
3.Current participation in an investigational drug trial. Participation in a noninterventional study (including observational studies, registry
studies, and studies requiring blood collections without administration of study drug) and screening for another Vertex study is permitted.
Subjects resuming participation in Part B of this study after enrolling in another qualifying Vertex study must not meet Part B Exclusion Criteria 1 through 3, and also must not meet any of the following criteria:
4.Pregnant and nursing females. All female subjects must have a
negative pregnancy test at the Returning Visit before receiving the first dose of study drug.
5.History of drug intolerance in another qualified Vertex study that
would pose an addition risk to the subject in the opinion of the
investigator. If protocol-defined interruption criteria is met in another
qualified Vertex study, then the subject must remain on study drug
interruption until the subject meets criteria in Section 9.8 and receives approval by the medical monitor to resume study drug dosing in this study.
6.Has received the first dose of st
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method