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Trial record 41 of 76 for:    ALPHA-1-ANTITRYPSIN DEFICIENCY

The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency (STAMP)

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ClinicalTrials.gov Identifier: NCT00301366
Recruitment Status : Completed
First Posted : March 10, 2006
Results First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Alpha 1-Antitrypsin Deficiency
Intervention: Drug: alpha-1 proteinase inhibitor (human)

  Participant Flow

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 12 June 2006, last-subject-last-visit was 20 March 2007. The study was performed in 10 clinical sites, 8 sites in the United States and 2 sites in the United Kingdom.

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-1MP Treatment Group All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks

Participant Flow:   Overall Study
    Alpha-1MP Treatment Group
STARTED   38 
COMPLETED   37 
NOT COMPLETED   1 
Adverse Event                1 



  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
Entered Study No text entered.

Baseline Measures
   Entered Study 
Overall Participants Analyzed 
[Units: Participants]
 38 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   32 
>=65 years   6 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.4  (8.63) 
Gender 
[Units: Participants]
 
Female   15 
Male   23 
Region of Enrollment 
[Units: Participants]
 
United States   35 
United Kingdom   3 


  Outcome Measures

1.  Primary:   Treatment-emergent Adverse Events (TEAEs) Defined as Any Adverse Event (AE) Occurring During or After the Start of the First Study Drug Infusion.   [ Time Frame: 24 weeks ]


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


Publications:

Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT00301366     History of Changes
Other Study ID Numbers: 11815
First Submitted: March 8, 2006
First Posted: March 10, 2006
Results First Submitted: August 28, 2009
Results First Posted: August 19, 2014
Last Update Posted: August 19, 2014