Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults

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Brief Title

Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults

Official Title

Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency.

Brief Summary

      The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1
      Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1
      Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult
      Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug
      on a weekly schedule for 24 weeks.
    

Detailed Description

      The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP
      to Prolastin® in subjects with Alpha1-antitrypsin deficiency.

      This study is divided into three 8-week treatment sequences including an initial 8-week
      double-blind treatment period (with one of the 2 study drugs), a second 8-week double-blind
      treatment period (with the other study drug), and a third 8-week open-label treatment period
      (with Alpha-1 MP).
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7


Condition

Alpha 1-Antitrypsin Deficiency

Intervention

Alpha-1 MP

Study Arms / Comparison Groups

 1 Alpha-1 MP
Description:  Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

May 2006

Completion Date

February 2007

Primary Completion Date

February 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Documented diagnosis of congenital Alpha1-antitrypsin deficiency

          -  Must be receiving augmentation therapy with plasma-derived (human) Alpha1-Proteinase
             Inhibitor (Prolastin®) for at least one month prior to study entry.

          -  Signed written informed consent prior to initiation of any study related procedures

        Exclusion Criteria:

          -  Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling
             to practice adequate contraception throughout the study

          -  Use of systemic steroids within the 2 weeks prior to receiving study treatment (this
             does not include the use of inhaled steroids used on a routine or as needed basis).

          -  Subjects who have had exacerbations of their disease within one month of trial entry.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kim Hanna, MSc, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00295061

Organization ID

11816



Study Sponsor

Grifols Therapeutics LLC


Study Sponsor

Kim Hanna, MSc, Study Director, Grifols Therapeutics LLC


Verification Date

August 2014