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