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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00301366 |
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Date of registration:
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08/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Multi-center, Open-label Trial to Evaluate the Safety and Tolerability of Alpha-1 MP in Subjects With Alpha-1-antitrypsin (AAT) Deficiency |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00301366 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Netherlands
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Poland
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United Kingdom
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United States
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Contacts
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Name:
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Kim Hanna, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Grifols Therapeutics Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Documented diagnosis of congenital Alpha1-antitrypsin deficiency
- Documented forced expiratory volume in 1 second (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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alpha 1-Antitrypsin Deficiency
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Intervention(s)
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Drug: alpha-1 proteinase inhibitor (human)
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Primary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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