Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency

Completed · Phase 2/Phase 3

Conditions studied: Alpha 1-Antitrypsin Deficiency

In brief

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.

Key facts

Study ID

NCT00460096

Run by

Kamada, Ltd.

People needed

50

Starts

2007-03-01

Expected to finish

2007-09-01

Last updated by the study team

2007-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Jewish Medical and Research Center — Denver, Colorado, United States
• University of Florida School of Medicine — Gainesville, Florida, United States
• The University of Texas Health Center at Tyler — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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