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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Alpha 1-Antitrypsin Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 Alpha-1 MP

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

Group Type EXPERIMENTAL

Alpha-1 MP

Intervention Type DRUG

alpha-1 proteinase inhibitor (human), 60 mg/kg body weight

2 Prolastin

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

Group Type ACTIVE_COMPARATOR

alpha-1 proteinase inhibitor (human)

Intervention Type DRUG

Prolastin

Interventions

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Alpha-1 MP

alpha-1 proteinase inhibitor (human), 60 mg/kg body weight

Intervention Type DRUG

alpha-1 proteinase inhibitor (human)

Prolastin

Intervention Type DRUG

Other Intervention Names

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Alpha-1 antitrypsin (AAT) TAL6004 Alpha-1 antitrypsin (AAT) BAY x 5747 BAY 10-5233 TAL-05-00007

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No