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COMPLETEDPHASE2/PHASE3

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

Randomized Double-Blind Comparison of an Alpha-1 Proteinase Inhibitor (Kamada API) With a Currently Marketed API Product in Individuals With Alpha-1 Antitrypsin Deficiency

NCT00460096•Kamada, Ltd.

View on ClinicalTrials.gov

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 circulating levels of this protein. Subjects with AAT deficiency are at increased risk for developing chronic obstructive pulmonary disease (COPD). It is believed that this is the result of the chronic activity of elastase released by cells continually present in the lungs in low numbers. This study is a randomized, double-blind comparison of Kamada API, an Alpha-1-Proteinase Inhibitor with a currently marketed API product.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent.
•2. "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.
•3. At least 18 years of age.
•4. 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
•5. For actively treated subjects, agreement to not receive any exogenous API product (i.e. washout) for five weeks prior to first study infusion.
•6. Use of an effective means of contraception during the 24 weeks of study drug administration (this is applicable to both sexes).
•7. 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 Criteria

•1. Laboratory evidence of severe IgA deficiency (from medical history or by IgA testing at screening of at least 20% of lower range).
•2. Current smoker or a history of smoking within the past 3 months.
•3. History of allergy to plasma proteins.
•4. Participation in another experimental drug or device trial within the past 30 days.
•5. Evidence of uncontrolled hypertension (systolic ≥180 mm Hg, and/or diastolic ≥ 110 mm Hg on 3 consecutive occasions in the supine position)
•6. Pulse ≥ 120/min (prior to the 1st infusion).
•7. Abnormal screening or baseline laboratory measurements that in the opinion of the Investigator would affect subject safety.
•8. Pregnancy or lactation.
•9. Current life-threatening malignancy.
•10. Previous organ transplant recipient.
+8 more criteria

Locations (3)

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

Key Dates

Start Date

March 1, 2007

Completion Date

September 1, 2007

Last Updated

October 17, 2007

Enrollment

ESTIMATED participants

Conditions

Alpha 1-Antitrypsin Deficiency

Interventions

Kamada-API

DRUG

A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)

NCT06389877

Alpha 1-Antitrypsin Deficiency

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RECRUITINGPHASE1

Gene Therapy for Alpha 1- Antitrypsin Deficiency

NCT06996756

Alpha 1-Antitrypsin Deficiency

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RECRUITINGPHASE3

Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation"

NCT04204252

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)

Gene Therapy for Alpha 1- Antitrypsin Deficiency

Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation"

Alpha-1 Research Registry

Epigenetic Regulation of Immunity in Alpha-1 Anti-trypsin Deficiency

Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease