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

This study has been completed.
Information provided by:
Grifols Therapeutics Inc. Identifier:
First received: March 8, 2006
Last updated: September 26, 2008
Last verified: September 2008

The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.

Condition Intervention Phase
Alpha 1-Antitrypsin Deficiency
Drug: alpha-1 proteinase inhibitor (human)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center, Open-Label Trial to Evaluate the Safety and Tolerability of Alpha-1 MP in Subjects With Alpha-1-Antitrypsin (AAT) Deficiency

Resource links provided by NLM:

Further study details as provided by Grifols Therapeutics Inc.:

Primary Outcome Measures:
  • treatment-emergent adverse events [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • all adverse events [ Time Frame: 24 weeks ]
  • Laboratory data outside normal range [ Time Frame: 24 weeks ]

Enrollment: 38
Study Start Date: May 2006
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: Entered study Drug: alpha-1 proteinase inhibitor (human)
60 mg/kg weekly for 20 weeks
Other Names:
  • Prolastin
  • Alpha-1 antitrypsin (AAT)
  • BAY x 5747
  • BAY 10-5233
  • TAL-05-00007

Detailed Description:

The objective of this clinical trial (STAMP: Safety and Tolerability of Alpha-1 Modified Process) is to study the safety and tolerability of Alpha-1 MP in adult Alpha 1-antitrypsin deficient subjects as reported over 20 weeks of therapy. The primary objective is to describe the nature and frequency of treatment-emergent adverse events with "treatment-emergent" defined as any adverse event occurring after the start of the first study drug infusion.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented diagnosis of congenital Alpha1-antitrypsin deficiency
  • Documented FEV1 between 20% - 80% of predicted value within last 6 months.
  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00301366

United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610-0225
University of Miami School of Medicine
Miami, Florida, United States, 33101
United States, New York
St Lukes-Roosevelt Hospital Center, New York
New York, New York, United States, 10019
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Health Center at Tyler
Tyler, Texas, United States, 75708-3154
Uniwersytetu Medycznego w Lodzi, Klinika Pneumonologii i Alergologii
Lodz, Poland, 90 - 153
United Kingdom
University of Cambridge - Cambridge Institute for Medical Research
Cambridge, England, United Kingdom, CB2 2XY
University Teaching Hospital of Edinburgh
Edinburgh, Scotland, United Kingdom, EH8 9AG
Sponsors and Collaborators
Grifols Therapeutics Inc.
Study Director: Eric Batson, MD Grifols Therapeutics Inc.
  More Information

Additional Information:
Publications: Identifier: NCT00301366     History of Changes
Other Study ID Numbers: 11815
Study First Received: March 8, 2006
Last Updated: September 26, 2008
Health Authority: United States: Food and Drug Administration
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Grifols Therapeutics Inc.:
alpha 1-Antitrypsin Deficiency
alpha 1-Antitrypsin
pulmonary emphysema

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Pathologic Processes
Alpha 1-Antitrypsin
Protein C Inhibitor
Protease Inhibitors
Trypsin Inhibitors
Serine Proteinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on July 24, 2014