Phase 2Terminated
A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF (ANAKIN)
A Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic Fibrosis
- Sponsor
- Heidelberg University (Academic or other)
- Enrolment
- 33 enrolled
- Conditions
- Cystic Fibrosis, 10011762
- Interventions
- Anakinra
- Ages
- children, adults, older adults
- Registry
- NCT03925194
Full record on ClinicalTrials.gov
From the registry
OBJECTIVES Primary: To evaluate efficacy of treatment with anakinra in subjects with CF who are ≥ 12 years of age by means of lung clearance index (LCI). Secondary To evaluate safety and tolerability of treatment with anakinra as well as to investigate further effects of anakinra on lung function and quality of life (QOL) in subjects with CF.
Primary outcomes
- Absolute pre-post change of the lung clearance index (LCI)
History
Last registry update
Study completion
Primary completion
Started
Registered