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

LFB

Status: Completed

Conditions: Alpha 1-Antitrypsin Deficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT01676688

AlfaDom

Details and patient eligibility

About

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

Full description

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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.