Status:
TERMINATED
Aralast alpha1-proteinase Inhibitor Surveillance Study
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Alpha1-antitrypsin Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older
- Diagnosis of AAT deficiency associated emphysema
- Active prescription for augmentation therapy with ARALAST
- On service with Coram (a speciality pharmacy provider)
- Signed and dated informed consent
Exclusion
- Clinically significant medical (other than COPD), psychiatric, or cognitive illness that, in the opinion of Coram or the sponsor or the investigator, may compromise subject safety or compliance (such as end stage renal or hepatic or heart disease, or metastatic cancer or any difficulty in communicating over the telephone lines)
- Previous treatment with ARALAST (i.e. subjects who had previously received and then discontinued ARALAST augmentation therapy and are now restarting ARALAST will be excluded from the study)
Key Trial Info
Start Date :
June 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00313144
Start Date
June 9 2006
End Date
May 1 2009
Last Update
May 26 2021
Active Locations (1)
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1
Adupa Rao, MD
San Marino, California, United States, 91108