EUCTR2012-000389-39-GBActive, not recruitingPhase 1
A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 125
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •- Subjects entering the ivacaftor arm must have completed the assigned study drug treatment duration in the previous study (Study 110 or Study 111), must have completed the previous study but do not wish to enroll in the ivacaftor arm, or must have completed the previous study but do not meet the inclusion criteria of the ivacaftor arm.
- •- Subjects entering the observational arm must have completed at least 4 weeks of study drug treatment in their previous study (Study 110 or Study 111)
- •- Females of childbearing potential entering the ivacaftor arm must not be pregnant
- •- Subjects entering the ivacaftor arm must be willing to comply with contraception requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 31
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 87
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Ivacaftor Arm Only:
- •- History of any illness or condition that might confound the results of the study or pose an additional risk in administering ivacaftor to the subject
- •- Use of any inhibitors or inducers of cytochrome P450 (CYP) 3A
- •- Evidence of cataract or lens opacity at or before the Day 1 Visit
Investigators
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