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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000064-35S1
Application #
6218455
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
35
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of Utah
Department
Type
DUNS #
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
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