AUGMENTATION THERAPY FOR CONGENITAL ALPHA1 PROTEINASE INHIBITOR THERAPY

$1,624M01FY2001RRNIH

University Of Utah, Salt Lake City UT

Investigators

Linked publications & trials

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Abstract

This is a multicenter, category D study designed to test to the efficacy and safety of a new (1-antitrypsin preparation. The Utah site has recruited five subjects, and all of them were evaluated. All participants will continue to receive 60 mg/kg/week of the new preparation for up to two years. Bronchoalveolar lavages were performed on all subjects at enrollment (to establish baseline values), and again a week after the sixth infusion of (1-PI or control product. Data analyses are currently being done by the industrial sponsor. No reports are yet available, although the drug does appear to be safe.

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