Status:
COMPLETED
Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency
Lead Sponsor:
Kamada, Ltd.
Conditions:
Alpha 1-Antitrypsin Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
Alpha-1 Antitrypsin Deficiency, also called Alpha-1-Proteinase Inhibitor (API) deficiency, is a genetic disorder characterized by the production of an abnormal amount of AAT protein and reduced circul...
Eligibility Criteria
Inclusion
- Signed informed consent.
- "At-risk" alleles associated with serum AAT \< 11 μM including null alleles and deficiency alleles. This must be documented in the subject's history or laboratory tests performed at screening.
- At least 18 years of age.
- Evidence of lung disease related to AAT deficiency, identified by at least one of the following:
- FEV1\<80% predicted (post BD); or
- Loss of lung function over a one year period of greater than 35ml in FEV1; or
- HRCT evidence of pulmonary emphysema
- For actively treated subjects, agreement to not receive any exogenous API product (i.e. washout) for five weeks prior to first study infusion.
- Use of an effective means of contraception during the 24 weeks of study drug administration (this is applicable to both sexes).
- Subjects on the BAL, bronchial brushing/biopsy group must be on inhaled corticosteroids at a stable dose two weeks prior the first Bronchoscopy and throughout the dosing period up the final bronchoscopy.
Exclusion
- Laboratory evidence of severe IgA deficiency (from medical history or by IgA testing at screening of at least 20% of lower range).
- Current smoker or a history of smoking within the past 3 months.
- History of allergy to plasma proteins.
- Participation in another experimental drug or device trial within the past 30 days.
- Evidence of uncontrolled hypertension (systolic ≥180 mm Hg, and/or diastolic ≥ 110 mm Hg on 3 consecutive occasions in the supine position)
- Pulse ≥ 120/min (prior to the 1st infusion).
- Abnormal screening or baseline laboratory measurements that in the opinion of the Investigator would affect subject safety.
- Pregnancy or lactation.
- Current life-threatening malignancy.
- Previous organ transplant recipient.
- History of infection with HCV, HBV and/or HIV 1 or 2, or (at baseline) infection indicated by laboratory measurements obtained at screening.
- Acute respiratory tract infection or COPD exacerbation which required antibiotic and/or systemic steroid treatment within the past 6 weeks. Patient can be re-evaluated for enrollment 6 weeks after an exacerbation.
- Any other condition which in the judgment of the investigator may interfere with the conduct of the study.
- If an adequate home health care agency cannot be established by Centric Health Resources due to a potential subject's geographical location.
- Exclusion criteria for subjects entering into the BAL and bronchial biopsy/brushing:
- FEV1 \< 45% predicted (post-BD).
- Inability to undergo bronchoscopy.
- Allergy to lidocaine.
- Exacerbation of COPD in the previous 6 weeks.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00460096
Start Date
March 1 2007
End Date
September 1 2007
Last Update
October 17 2007
Active Locations (3)
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1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
2
University of Florida School of Medicine
Gainesville, Florida, United States, 32610
3
The University of Texas Health Center at Tyler
Tyler, Texas, United States, 75708-3154