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
Results First Received: August 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alpha 1-Antitrypsin Deficiency
Interventions: Drug: Alpha-1 MP
Drug: alpha-1 proteinase inhibitor (human)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First-subject-first-dose was on 22 May 2006, Last-subject-last-visit was on 28 Feb 2007. The trial was performed at 6 clinical sites in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Participant Flow:   Overall Study
    Alpha-1 MP / Prolastin     Prolastin / Alpha-1 MP  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
Alpha-1 MP / Prolastin Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
Prolastin / Alpha-1 MP Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
Total Total of all reporting groups

Baseline Measures
    Alpha-1 MP / Prolastin     Prolastin / Alpha-1 MP     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     2     2     4  
Age  
[units: years]
Mean ± Standard Deviation
  58.4  ± 6.86     57.0  ± 9.33     57.7  ± 8.04  
Gender  
[units: participants]
     
Female     6     8     14  
Male     6     4     10  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



  Outcome Measures

1.  Primary:   Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7   [ Time Frame: Day 0 to Day 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Henry Li
Organization: Grifols Therapeutics
phone: 1-800-520-2807
e-mail: henry.li@grifols.com


No publications provided by Grifols Therapeutics Inc.

Publications automatically indexed to this study:

Responsible Party: Gerald Klein, MD, Chief Medical Officer, Vice President of Medical and Clinical Affairs, Talecris Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00295061     History of Changes
Other Study ID Numbers: 11816
Study First Received: February 20, 2006
Results First Received: August 28, 2009
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration