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Trial record 30 of 79 for:    ALPHA-1-ANTITRYPSIN DEFICIENCY

Pharmacokinetic Study of ARALAST (Human Alpha1- PI)

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ClinicalTrials.gov Identifier: NCT00242385
Recruitment Status : Completed
First Posted : October 20, 2005
Results First Posted : July 20, 2011
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Shire

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Alpha 1-Antitrypsin Deficiency
Interventions: Biological: Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor
Biological: Dose of 60 mg/kg alpha1-proteinase inhibitor

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment was conducted at seven clinical sites in Australia (4 sites) and New Zealand (3 sites) beginning in December 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 25 enrolled subjects were assigned to groups.

Reporting Groups
  Description
ARALAST Fr. IV-1 Then Aralast Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
ARALAST Then ARALAST Fr. IV-1 Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.

Participant Flow for 2 periods

Period 1:   Period 1
    ARALAST Fr. IV-1 Then Aralast   ARALAST Then ARALAST Fr. IV-1
STARTED   14   11 
COMPLETED   14   11 
NOT COMPLETED   0   0 

Period 2:   Period 2
    ARALAST Fr. IV-1 Then Aralast   ARALAST Then ARALAST Fr. IV-1
STARTED   14   11 
COMPLETED   14   11 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Subjects With Severe Congenital α1-PI Deficiency Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.

Baseline Measures
   Subjects With Severe Congenital α1-PI Deficiency 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Years]
Median (Full Range)
 59 
 (20 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  32.0% 
Male      17  68.0% 
Region of Enrollment 
[Units: Participants]
 
Australia   14 
New Zealand   11 


  Outcome Measures

1.  Primary:   Area Under the Curve/Dose   [ Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion ]

2.  Secondary:   Total Area Under the Curve Per Dose   [ Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion ]

3.  Secondary:   Systemic Clearance (CL)   [ Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion ]

4.  Secondary:   Mean Residence Time (MRT)   [ Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion ]

5.  Secondary:   Apparent Volume of Distribution at Steady State   [ Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion ]

6.  Secondary:   Terminal Half-life   [ Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion ]

7.  Secondary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion ]

8.  Secondary:   Time to Maximum α1-PI Concentration Post-infusion (Tmax)   [ Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion ]

9.  Secondary:   Incremental Recovery   [ Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion ]

10.  Secondary:   Adverse Events (AEs)   [ Time Frame: Throughout study period (7 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: David Gelmont, MD, Global Medical Director, Head of Specialty Products TA, BioTherapeutics
Organization: Baxter Healthcare Corporation
e-mail: david_gelmont@baxter.com



Responsible Party: David Gelmont, MD, Global Medical Director, Head of Specialty Products TA, BioTherapeutics, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00242385     History of Changes
Other Study ID Numbers: 460501
First Submitted: October 19, 2005
First Posted: October 20, 2005
Results First Submitted: February 15, 2011
Results First Posted: July 20, 2011
Last Update Posted: November 24, 2017