AL1TER™: Alpha-1 Therapy, Evaluation, and Research Patient Registry

Completed

Conditions studied: Alpha-1 Anti-trypsin Deficiency

In brief

This is a longitudinal, observational, non-interventional registry study, designed to collect both retrospective and prospective real world data, on patients receiving Alpha-1 augmentation therapy in the home through Coram Specialty Infusion.The data will be collected from standard Coram homecare forms, as well as patient reported case forms.

Key facts

Study ID

NCT01974830

Run by

Coram Clinical Trials

People needed

120

Starts

2013-10-01

Expected to finish

2019-09-06

Last updated by the study team

2019-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet the following criteria to participate in this study:
• Signed informed consent Either male or female, ≥18yrs of age requiring α1-PI therapy Agree to the use of Coram's infusion services upon entry into AL1TER Registry

You may not qualify if…

• Patients will be excluded from participation in the study for any of the following reasons:
• Currently using an insurance provider for which Coram's services are not covered/authorized Have previously participated in the AL1TER Registry and revoked consent to the use of their Protected Health Information in theAL1TER Registry database Under the age of 18, or member of a vulnerable population (prisoner, unable to understand the English version of the consent, or unable to sign consent themselves)

Where it is running

• Coram Clinical Trials — Centennial, Colorado, United States

Full record on ClinicalTrials.gov

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