Brief Title
Safety Study of Alfalastin (Human Alpha-1 Antitrypsin) Administered at Home
Official Title
Safety Study of Alfalastin (Human Alpha-1 Antitrypsin, 33.33 mg/ml) Administered at Home to Patients Suffering From Severe Forms of Primary Deficiency in Alpha-1 Antitrypsin, Phenotype PIZZ or PISZ, With Pulmonary Emphysema.
Brief Summary
The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at
home or in out-of hospital locations.
Detailed Description
Non interventional, observational, longitudinal, prospective, multicenter, non comparative
study.
Study Type
Observational
Condition
Alpha 1-Antitrypsin Deficiency
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
17
Start Date
January 2012
Completion Date
October 2012
Primary Completion Date
September 2012
Eligibility Criteria
Participation Criteria:
- Patients above 18 y.o,
- suffering from severe forms of primary alpha-1 antitrypsin deficiency, phenotype PiZZ
or PiSZ with pulmonary emphysema,
- currently treated as per routine practice, once a week, by ALFALASTIN® at home or in
out-of-hospital location
- and having signed informed consent.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Cuvelier Antoine, Prof., ,
Administrative Informations
NCT ID
NCT01676688
Organization ID
AlfaDom
Responsible Party
Sponsor
Study Sponsor
Laboratoire français de Fractionnement et de Biotechnologies
Study Sponsor
Cuvelier Antoine, Prof., Study Director, Pneumology - CHU Rouen, France
Verification Date
August 2012