Phase 3
Completed N=192
Rollover Study of VX-770 in Cystic Fibrosis Subjects
Source: ClinicalTrials.gov NCT01117012 ↗Enrolled (actual)
192
Serious AEs
36.5%
Results posted
Jul 2015
Primary outcomePrimary: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) — 190; 70 participants
Summary
The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) |
190; 70 | — |
| SECONDARY Annualized Rate of Decline From Study 105 Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 96 |
-0.30; -1.23 | — |
| SECONDARY Absolute Change From Study 105 Baseline in Percent Predicted FEV1 Through Week 96 |
9.2585; -0.4422; 9.8194; 0.1581 | — |
| SECONDARY Absolute Change From Study 105 Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 96 |
7.43; -1.94; 10.05; 0.77 | — |
| SECONDARY Annualized Pulmonary Exacerbation Event Rate |
0.463; 0.658 | — |
| SECONDARY Annualized Duration of Pulmonary Exacerbation Events |
10.89; 17.27 | — |
| SECONDARY Absolute Change From Study 105 Baseline in Weight Through Week 96 |
4.03; 1.26; 4.93; 2.62 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who have completed the assigned study treatment in Study 102 or Study 103
- Participants who are females of childbearing potential must have a negative urine pregnancy test on Day 1 (first dose of VX-770)
- Participants who are able to understand and comply with protocol requirements, restrictions, and instructions and likely to complete the study as planned, as judged by the investigator
- Participants of child bearing potential and who are sexually active must meet the contraception requirements
- Participants must sign the informed consent form (ICF), and where appropriate, assent must be obtained
Exclusion Criteria
- Participants with a history of any illness or condition 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
- Participants with a history of study treatment intolerance as observed in their previous VX-770 study that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject
- Participants who are pregnant, planning a pregnancy, breast-feeding, or not willing to follow contraception requirements
- Participants taking any inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4), including certain herbal medications (for example, St. John's Wort) and grapefruit/grapefruit juice
Data sourced from ClinicalTrials.gov (NCT01117012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.