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

October 16, 2007 updated by: Kamada, Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida School of Medicine
    • Texas
      • Tyler, Texas, United States, 75708-3154
        • The University of Texas Health Center at Tyler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  11. History of infection with HCV, HBV and/or HIV 1 or 2, or (at baseline) infection indicated by laboratory measurements obtained at screening.
  12. 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.
  13. Any other condition which in the judgment of the investigator may interfere with the conduct of the study.
  14. 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:

  1. FEV1 < 45% predicted (post-BD).
  2. Inability to undergo bronchoscopy.
  3. Allergy to lidocaine.
  4. Exacerbation of COPD in the previous 6 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy

Secondary Outcome Measures

Outcome Measure
Safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kamada, Ltd.

Investigators

  • Principal Investigator: Robert A Sandhaus, M.D., National Jewish Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

April 12, 2007

First Submitted That Met QC Criteria

April 12, 2007

First Posted (Estimate)

April 13, 2007

Study Record Updates

Last Update Posted (Estimate)

October 17, 2007

Last Update Submitted That Met QC Criteria

October 16, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kamada API-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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