Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients
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ClinicalTrials.gov Identifier: NCT00499837 |
Recruitment Status
:
Completed
First Posted
: July 12, 2007
Last Update Posted
: June 9, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | July 11, 2007 | |||
First Posted Date ICMJE | July 12, 2007 | |||
Last Update Posted Date | June 9, 2016 | |||
Study Start Date ICMJE | September 2007 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety and airway inflammation [ Time Frame: days 1,7,14,21,28,35,42,49,56,63 ] | |||
Original Primary Outcome Measures ICMJE |
Safety and airway inflammation | |||
Change History | Complete list of historical versions of study NCT00499837 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Sputum microbiology, pulmonary function and serum CRP [ Time Frame: days 1,7,14,21,28,35,42,49,56,63 ] | |||
Original Secondary Outcome Measures ICMJE |
Sputum microbiology, pulmonary function and serum CRP | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients | |||
Official Title ICMJE | Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients | |||
Brief Summary | Cystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs produce considerable quantity of thick, sticky secretions that clog the airways, promote bacterial growth and lead to chronic obstruction, inflammation and destruction of the airways. The purpose of this study is to collect data about the resolution of the chronic inflammatory state in addition to assure the safety of the therapy in CF patients. |
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Detailed Description | In CF patients the unregulated inflammatory response overwhelms the normal protease (elastase)/antiprotease (AAT) balance, leading to the accumulation of elastase in the lung, destruction of the lung architecture, severe pulmonary dysfunction, and ultimately death. Administration of AAT is to address the elastase/antiprotease imbalance in order to prevent destruction of the lung tissue and reduce the inflammatory dysregulation that causes pulmonary dysfunction. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Cystic Fibrosis | |||
Intervention ICMJE | Drug: Aerosolized, human, plasma-derived Alpha-1 Antitrypsin | |||
Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
21 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | July 2008 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 5 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Israel | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00499837 | |||
Other Study ID Numbers ICMJE | Kamada-AAT (inhaled)-003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement |
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Responsible Party | Kamada, Ltd. | |||
Study Sponsor ICMJE | Kamada, Ltd. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Kamada, Ltd. | |||
Verification Date | April 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |