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Aralast alpha1-Proteinase Inhibitor Surveillance Study

Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alpha 1-Antitrypsin Deficiency

Intervention: ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Baxter Healthcare Corporation

Official(s) and/or principal investigator(s):
Adupa Rao, MD, Principal Investigator, Affiliation: Coram

Summary

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.

Clinical Details

Official title: ARALAST alpha1-Proteinase Inhibitor (α1-PI) Surveillance Study

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: HRQoL and HCRU data

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

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

Starting date: June 2006
Last updated: February 5, 2008

Page last updated: June 20, 2008

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