Alpha 1-Antitrypsin DeficiencyNCT01676688
Safety Study of Alfalastin (Human Alpha-1 Antitrypsin) Administered at Home
An observational study of Alpha 1-Antitrypsin Deficiency, run by Laboratoire français de Fractionnement et de Biotechnologies.
Trial summary
The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at home or in out-of hospital locations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alpha 1-Antitrypsin Deficiency
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
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.
The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at home or in out-of hospital locations.
Read the detailed description
Non interventional, observational, longitudinal, prospective, multicenter, non comparative study.
- Conditions
- Alpha 1-Antitrypsin Deficiency
- Keywords
- alpha-1 antitrypsin, deficiency, Alfalastin, safety
- Medical subject headings
- alpha 1-Antitrypsin Deficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha 1-Antitrypsin DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cuvelier Antoine, Prof., Study director, Pneumology - CHU Rouen, FranceMornex Jean-François, Prof, Study chair, Pneumology - CHU Lyon, FranceThabut Gabriel, MD, Study chair, Pneumology - Hôpital Bichat Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676688
- Sponsor's protocol ID
- AlfaDom
- Status last verified
- Oct 2023
- First submitted
- 29 Aug 2012
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01676688
- Acronym / sponsor ID
- AlfaDom
- Conditions
- Alpha 1-Antitrypsin Deficiency
- Keywords
- alpha-1 antitrypsin, deficiency, Alfalastin, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Laboratoire français de Fractionnement et de BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
Related trials for Alpha 1-Antitrypsin Deficiency
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Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
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AATD-Liver Scan Study
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A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cuvelier Antoine, Prof. study director
Pneumology - CHU Rouen, France
Mornex Jean-François, Prof study chair
Pneumology - CHU Lyon, France
Thabut Gabriel, MD study chair
Pneumology - Hôpital Bichat Paris, France
Questions about this trial
What is this clinical trial studying?
An observational study of Alpha 1-Antitrypsin Deficiency, run by Laboratoire français de Fractionnement et de Biotechnologies.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.