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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01676688

Enrollment

Registered

2012-08-31

Start date

2012-01-31

Completion date

2012-10-31

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alpha 1-Antitrypsin Deficiency

Keywords

alpha-1 antitrypsin, deficiency, Alfalastin, safety

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Outcome results