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Aerosolized, human, plasma-derived Alpha-1 Antitrypsin

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |Kamada Ltd.|Last Updated: Jun 9, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

Aerosolized, human, plasma-derived Alpha-1 Antitrypsin · 1 trial · 1 indication

Phase 2 1
NCT00499837Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis PatientsCystic Fibrosis
COMPLETED21 Analytics
PHASE2COMPLETED
Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and airway inflammation
days 1,7,14,21,28,35,42,49,56,63

Secondary Endpoints

Sputum microbiology, pulmonary function and serum CRP
days 1,7,14,21,28,35,42,49,56,63
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
80 mg/kg AAT inhaledEXPERIMENTAL80 mg/kg AAT inhaled
Placebo inhaledPLACEBO_COMPARATORPlacebo inhaled

Interventions

NameTypeDescription
Aerosolized, human, plasma-derived Alpha-1 AntitrypsinDRUG -
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Eligibility Criteria

Age Range5 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of CF by clinical symptoms and positive sweat test or disease inducing mutation. * Age \>5 yrs * Proven ability to perform reproducible PFTs * FEV1 \>25% predicted * Steady disease state for 3 months and no decrease in lung function exceeding 10% during that period *...

Countries:Israel
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