Full Text View
Tabular View
No Study Results Posted
Related Studies
Aralast alpha1-Proteinase Inhibitor Surveillance Study
This study has been completed.
Study NCT00313144   Information provided by Baxter Healthcare Corporation
First Received: April 10, 2006   Last Updated: June 25, 2009   History of Changes

April 10, 2006
June 25, 2009
June 2006
December 2008   (final data collection date for primary outcome measure)
HRQoL and HCRU data [ Time Frame: At study completion ] [ Designated as safety issue: No ]
HRQoL and HCRU data [ Time Frame: at study completion ]
Complete list of historical versions of study NCT00313144 on ClinicalTrials.gov Archive Site
 
 
 
Aralast alpha1-Proteinase Inhibitor Surveillance Study
ARALAST alpha1-Proteinase Inhibitor (α1-PI) Surveillance Study

The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of AAT-deficient subjects who are initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory analyses to evaluate the safety of long-term administration of ARALAST.

Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every 6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw portion of the study, which will also include assessments of antibodies to ARALAST, and chemistry panel. Subjects will be treated according to the prescribing (attending) physician's instructions based on the prescribing information given in the ARALAST package insert.

 
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Alpha 1-Antitrypsin Deficiency
Drug: ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
May 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00313144
Nancy Sullivan, Clinical Project Manager, Baxter Healthcare Corporation
450501
Baxter Healthcare Corporation
 
Principal Investigator: Adupa Rao, MD Coram
Baxter Healthcare Corporation
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP