Aralast alpha1-Proteinase Inhibitor Surveillance Study - Full Text View

Sponsor:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00313144

Purpose

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.

Condition	Intervention	Phase
Alpha 1-Antitrypsin Deficiency	Drug: ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	ARALAST alpha1-Proteinase Inhibitor (α1-PI) Surveillance Study

Resource links provided by NLM:

Genetics Home Reference related topics: alpha-1 antitrypsin deficiency

MedlinePlus related topics: Alpha-1 Antitrypsin Deficiency

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

HRQoL and HCRU data [ Time Frame: At study completion ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	June 2006
Study Completion Date:	May 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Weekly ARALAST infusions for 2 years, dose and mode of administration as prescribed by the physician

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313144

Locations

United States, California
Adupa Rao, MD
San Marino, California, United States, 91108

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Principal Investigator:

Adupa Rao, MD

Coram

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation ( Nancy Sullivan, Clinical Project Manager )
Study ID Numbers:	450501
Study First Received:	April 10, 2006
Last Updated:	June 25, 2009
ClinicalTrials.gov Identifier:	NCT00313144 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Alpha 1-Antitrypsin
Molecular Mechanisms of Pharmacological Action
Alpha 1-Antitrypsin Deficiency
Trypsin Inhibitors

Connective Tissue Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 09, 2009