Safety Study of Alfalastin (Human Alpha-1 Antitrypsin) Administered at Home

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier:
NCT01676688
First received: August 29, 2012
Last updated: November 8, 2012
Last verified: August 2012

August 29, 2012
November 8, 2012
January 2012
September 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01676688 on ClinicalTrials.gov Archive Site
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Safety Study of Alfalastin (Human Alpha-1 Antitrypsin) Administered at Home
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.

The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at home or in out-of hospital locations.

Non interventional, observational, longitudinal, prospective, multicenter, non comparative study.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients above 18 y.o, suffering from severe forms of primary alpha-1 antitrypsin deficiency, phenotype PiZZ or PiSZ with pulmonary emphysema, currently treated , once a week, as per routine practice by ALFALASTIN® at home or in out-of-hospital location.

Alpha 1-Antitrypsin Deficiency
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
October 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01676688
AlfaDom
No
Laboratoire français de Fractionnement et de Biotechnologies
Laboratoire français de Fractionnement et de Biotechnologies
Not Provided
Study Director: Cuvelier Antoine, Prof. Pneumology - CHU Rouen, France
Study Chair: Mornex Jean-François, Prof Pneumology - CHU Lyon, France
Study Chair: Thabut Gabriel, MD Pneumology - Hôpital Bichat Paris, France
Laboratoire français de Fractionnement et de Biotechnologies
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP