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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01676688
Other study ID # AlfaDom
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2012
Est. completion date October 2012

Study information

Verified date October 2023
Source Laboratoire français de Fractionnement et de Biotechnologies
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 ALFALASTINĀ® at home or in out-of-hospital location - and having signed informed consent.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Laboratoire français de Fractionnement et de Biotechnologies
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