The Comparison of the Pharmacokinetic, Safety and Tolerability of Alpha-1 MP and Prolastin in Adult alpha1-Antitrypsin Deficient Patients.
Information source: Talecris Biotherapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alpha 1-Antitrypsin Deficiency
Intervention: alpha-1 proteinase inhibitor (human) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Talecris Biotherapeutics
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: AUC
Secondary outcome: Standard pharmacokinetic parametersAUC ( 0-∞)
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
National Jewish Medical and Research Center, Denver, Colorado 80206, United States
University of Florida College of Medicine, Gainesville, Florida 32610-0225, United States
University of Miami School of Medicine, Miami, Florida 33101, United States
St Lukes-Roosevelt Hospital Center, New York, New York, New York 10019, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44122, United States
Temple University Hospital, Philadelphia, Pennsylvania 19140, United States
Medical University of South Carolina, Charleston, South Carolina 29425, United States
University of Texas Health Center at Tyler, Tyler, Texas 75708-3154, United States
Additional Information
The "Alpha-1 Foundation", dedicated to providing the leadership and resources that will result in increased research, improved health, worldwide detection and a cure for Alpha-1 Antitrypsin Deficiency AlphaNet, Inc devoted to improving the lives of individuals with Alpha-1 antitrypsin deficiency through comprehensive disease management services, clinical research administration, and consultative services
Starting date: May 2006
Ending date: March 2007
Last updated: September 27, 2007
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