Status:
COMPLETED
Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency
Lead Sponsor:
Baxalta now part of Shire
Collaborating Sponsors:
Arriva Pharmaceuticals, Inc.
Conditions:
Alpha1-antitrypsin Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha 1-antitrypsin defic...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older
- Endogenous plasma AAT levels \< 11 µM (\< 80 mg/dL)
- Baseline forced expiratory volume at one second (FEV1) that is \>= 50% of predicted, measured 30 minutes after a short-acting inhaled bronchodilator
- Baseline arterial oxygen percent saturation (SaO2) within the normal limits for the individual study site
- For subjects receiving an inhaled corticosteroid, β-2 agonist (eg, albuterol via metered dose inhaler \[MDI\]) or anticholinergic bronchodilator (eg, ipratropium bromide), treatment on a stable dose for at least 14 days prior to randomization
- If female of childbearing potential, negative urine pregnancy test within 3 days prior to randomization and agreement to employ adequate birth control measures
- No clinically significant abnormalities detected on a 12-lead electrocardiogram (ECG) performed no more than 7 days prior to randomization
- Baseline laboratory results, obtained no more than 7 days prior to randomization, meeting the following criteria:
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2 times upper limit of normal range (ULN)
- Serum total bilirubin \<= 2 times ULN
- \< 2+ proteinuria on urine dipstick
- Serum creatinine \<= 1.5 times ULN
- Absolute neutrophil count \>= 1500 cells/mm3
- Hemoglobin \>= 10.0 g/dL
- Platelet count \>= 100,000/mm3
- Signed informed consent
Exclusion
- Clinically significant pulmonary impairment, other than emphysema and/or chronic bronchitis
- Clinically significant cardiac, hemostatic, or neurologic impairment, or other significant medical condition that, in the opinion of the investigator, would affect subject safety or compliance
- Psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
- Acute exacerbation of emphysema (as defined in Section 8.5.10) within 28 days prior to randomization
- Pregnancy or lactation
- Known history of allergy to yeast products
- Medical history precluding the use of epinephrine or other rescue medication for treatment of anaphylaxis
- Use of antihistamines within 7 days prior to randomization
- Use of oral steroids, beta-blockers, or tricyclic antidepressants within 28 days prior to randomization
- Use of another investigational drug or investigational device within 28 days prior to randomization
- Any upper or lower respiratory infection within 28 days prior to randomization
Key Trial Info
Start Date :
January 7 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00161707
Start Date
January 7 2003
End Date
October 1 2003
Last Update
May 5 2021
Active Locations (4)
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1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
2
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
3
Cleveland Clinic Foundation, Department of Pulmonary and Critical Care Medicine
Cleveland, Ohio, United States, 44195
4
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708-3154