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

This study has been completed.
Sponsor:
Information provided by:
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00295061
First received: February 20, 2006
Last updated: August 28, 2014
Last verified: August 2014

February 20, 2006
August 28, 2014
May 2006
February 2007   (final data collection date for primary outcome measure)
Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7 [ Time Frame: Day 0 to Day 7 ] [ Designated as safety issue: No ]
The primary objective of this study was to demonstrate the pharmacokinetic comparability (geometric least square mean ratio of AUC between the Alpha-1 MP vs. Prolastin®, 90% confidence interval falls within 0.80-1.25, FDA Guidance as being "bioequivalent" between two treatments) of Alpha-1 MP to Prolastin® in subjects with alpha-1-anti-trypsin (AAT) deficiency by comparing AUC from Day 0 to Day 7 of plasma Alpha1-PI measured by the functional activity (potency) assay. AUC from Day 0 to Day 7 was calculated at steady state at the end of the first and second 8-week treatment periods during the 16-week double-blind, crossover phase.
AUC (0-7 days)
Complete list of historical versions of study NCT00295061 on ClinicalTrials.gov Archive Site
Not Provided
Standard phamacokinetic parametersAUC ( 0-∞)
Not Provided
Not Provided
 
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency.

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alpha 1-Antitrypsin Deficiency
  • Drug: Alpha-1 MP
    alpha-1 proteinase inhibitor (human), 60 mg/kg body weight
    Other Names:
    • Alpha-1 antitrypsin (AAT)
    • TAL6004
  • Drug: alpha-1 proteinase inhibitor (human)
    Prolastin
    Other Names:
    • Alpha-1 antitrypsin (AAT)
    • BAY x 5747
    • BAY 10-5233
    • TAL-05-00007
  • Experimental: 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
    Intervention: Drug: Alpha-1 MP
  • Active Comparator: 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
    Intervention: Drug: alpha-1 proteinase inhibitor (human)
Stocks JM, Brantly ML, Wang-Smith L, Campos MA, Chapman KR, Kueppers F, Sandhaus RA, Strange C, Turino G. Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha?-antitrypsin deficiency: a randomized study. BMC Clin Pharmacol. 2010 Sep 30;10:13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2007
February 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00295061
11816
No
Gerald Klein, MD, Chief Medical Officer, Vice President of Medical and Clinical Affairs, Talecris Biotherapeutics, Inc.
Grifols Therapeutics Inc.
Not Provided
Study Director: Kim Hanna, MSc Grifols Therapeutics Inc.
Grifols Therapeutics Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP