Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency
NCT00460096 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2007-10-17
Summary
The primary purpose of this Phase II/III study is to demonstrate that Kamada-API, a new API concentrate manufactured by Kamada Ltd., is comparable to a currently marketed API product.
Conditions
Interventions
- DRUG
-
Kamada-API
Sponsors & Collaborators
-
Kamada, Ltd.
lead INDUSTRY
Principal Investigators
-
Robert A Sandhaus, M.D. · National Jewish Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Completion
- 2007-09-30
Countries
- United States
Study Locations
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