NCT01676688

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

August 29, 2012

Last Update Submit

October 2, 2023

Conditions

Alpha 1-Antitrypsin Deficiency

Keywords

alpha-1 antitrypsindeficiencyAlfalastinsafety

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

alpha 1-Antitrypsin Deficiency

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubcutaneous EmphysemaEmphysemaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cuvelier Antoine, Prof.

    Pneumology - CHU Rouen, France

    STUDY DIRECTOR

  • Mornex Jean-François, Prof

    Pneumology - CHU Lyon, France

    STUDY CHAIR

  • Thabut Gabriel, MD

    Pneumology - Hôpital Bichat Paris, France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

October 3, 2023

Record last verified: 2023-10