A phase IIa, randomized, placebo-controlled, double-blind, cross-over study to evaluate safety and efficacy of subcutanous administration of anakinra in patients with cystic fibrosis. - ANAKI

Ruprecht-Karls-University Heidelberg, Medical Faculty0 个研究点目标入组 52 人开始时间: 2017年6月30日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•1. Age = 18 years (1st cohort). If justified by interim analysis, 18 > age = 12 years (2nd cohort),
•2. Informed consent,
•3. Sufficient fluency in German language,
•4. Confirmed diagnosis of cystic fibrosis,
•6. FEV1 = 50 % pred. at screening,
•7.LCl 2.5 = 7.05 at screening,
•8. Ability to performed study specific procedures,
•9. Oxyhaemoglobin saturation of = 90% on room air at screening,
•10. No recent changes in the medication for cystic fibrosis lung disease,
•11. Adequate bone marrow function,
•12. Adequate liver function,
•13. Adequate blood clotting,
•14. Negative serology for HIV, HBV, and HCV, negative Interferon-gamma release assay,
•15. Negative pregnancy test in women of childbearing potential,
•16. Use of adequate contraception in sexually active female subjects.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 27
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Expected non-compliance,
•2. Known allergy to anakinra or any ingredient of the pharmaceutical formulation of Kineret®,
•3. Planned (during the treatment) or recently completed immunization with attenuated (live) vaccine(s),
•4. Renal failure,
•5. History of tuberculosis or repeated detection of non-tuberculous mycobacteria from airway samples in the last 12 months,
•6. History of detection of Burkholderia cenocepacia species in the last 12 months,
•7. Colonization with multi-resistant Staphylococcus aureus (MRSA) and/or 4-multi-resistant gram negative (MRGN) Pseudomonas aeruginosa,
•8. Acute bronchopulmonary exacerbation,
•9. Signs of other active infection within 14 days prior to the screening,
•10. Immunosuppressive treatment due to organ transplantation, rheumatic or autoimmune diseases as well as treatment with Anakinra in the last 3 months before Day 1 of Period 1
•11. Recent Participation in another interventional trial,
•12. Current oral corticosteroid use,
•13. Current oxygen supplementation,
•14. Current treatment with etanercept,
•15. Medical history of lung transplantation,
•16. Pregnancy or nursing,
•17. Known hypersensitivity to hypertonic saline (used for induction of sputum).

发起方

Ruprecht-Karls-University Heidelberg, Medical Faculty