EUCTR2019-000750-63-GBActive, not recruitingPhase 1
A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation
AbbVie Deutschland0 sites189 target enrollmentStarted: June 26, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 189
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •*Adults 18 years or older
- •*Confirmed diagnosis of CF and homozygous for F508del CFTR mutation
- •*Lung function = 40% and = 90% of predicted normal for age, gender, and height
- •*Stable pulmonary status
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 189
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •*Cirrhosis with portal hypertension
- •*History of solid organ or hematopoietic transplantation
Investigators
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