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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)
Enrollment 38
Recruitment Details 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  
Arm/Group Title Alpha-1MP Treatment Group
Hide Arm/Group Description All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
Period Title: Overall Study
Started 38
Completed 37
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Entered Study
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  84.2%
>=65 years
6
  15.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
53.4  (8.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
15
  39.5%
Male
23
  60.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
United States 35
United Kingdom 3
1.Primary Outcome
Title Treatment-emergent Adverse Events (TEAEs) Defined as Any Adverse Event (AE) Occurring During or After the Start of the First Study Drug Infusion.
Hide Description An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product. The adverse event does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the medicinal product.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
38 subjects received study medication and one subject discontinued from the study due to an AE. Therefore, 37 subjects completed the study. 18 subjects were naive ((i.e., never having received previous Alpha-1 protease inhibitor augmentation therapy) and 19 subjects were non-naive.
Arm/Group Title Alpha-1 MP Treatment Group
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: Participants
Number of Participants Analyzed 38
Subjects experiencing TEAEs 26
Subjects with TEAEs <24 hrs. of A-1 MP infusion 17
Alpha-1 MP subjects with ≥1 drug-related TEAE 5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alpha-1MP Treatment Group
Hide Arm/Group Description All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
All-Cause Mortality
Alpha-1MP Treatment Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alpha-1MP Treatment Group
Affected / at Risk (%) # Events
Total   2/38 (5.26%)    
Infections and infestations   
Pneumonia  1/38 (2.63%)  1
Skin and subcutaneous tissue disorders   
Rash  1/38 (2.63%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alpha-1MP Treatment Group
Affected / at Risk (%) # Events
Total   26/38 (68.42%)    
Gastrointestinal disorders   
Nausea  6/38 (15.79%)  6
General disorders   
Chest pain  4/38 (10.53%)  4
Influenza like illness  2/38 (5.26%)  2
Chills  2/38 (5.26%)  2
Infections and infestations   
Nasopharyngitis  2/38 (5.26%)  2
Oral candidiasis  2/38 (5.26%)  2
Upper respiratory tract infection  6/38 (15.79%)  6
Urinary tract infection  5/38 (13.16%)  5
Musculoskeletal and connective tissue disorders   
Arthralgia  2/38 (5.26%)  2
Back pain  2/38 (5.26%)  2
Muscle spasms  2/38 (5.26%)  2
Nervous system disorders   
Dizziness  2/38 (5.26%)  2
Headache  2/38 (5.26%)  3
Psychiatric disorders   
Anxiety  2/38 (5.26%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  2/38 (5.26%)  2
Dyspnoea  2/38 (5.26%)  2
Pharyngolaryngeal pain  2/38 (5.26%)  2
Vascular disorders   
Hot flush  2/38 (5.26%)  2
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 investigator must send a draft manuscript of the publication or abstract to the sponsor, thirty days in advance of submission, in order to obtain approval prior to submission of the final version for publication. This will be reviewed promptly and approval will not be withheld unreasonably. In case of a difference of opinion between the sponsor and the investigator(s), the contents of the publication will be discussed in order to find a solution that satisfies both parties.
Results Point of Contact
Name/Title: Henry Li
Organization: Grifols Therapeutics
Phone: 1-800-520-2807
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