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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
History of Changes
  Purpose

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


Condition
Alpha 1-Antitrypsin Deficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laboratoire français de Fractionnement et de Biotechnologies:

Enrollment: 17
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676688

Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
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
  More Information

No publications provided

Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT01676688     History of Changes
Other Study ID Numbers: AlfaDom
Study First Received: August 29, 2012
Last Updated: November 8, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority
France: L’Agence nationale de sécurité du médicament et des produits de santé
France: Conseil National de l'Ordre des Médecins

Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:
alpha-1 antitrypsin
deficiency
Alfalastin
safety

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes
 Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013