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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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 July 24, 2014