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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: |
NCT00295061 |
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Date of registration:
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20/02/2006 |
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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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Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
ChAMP |
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Scientific title:
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Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency. |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00295061 |
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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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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
- Must be receiving augmentation therapy with plasma-derived (human) Alpha1-Proteinase
Inhibitor (Prolastin®) for at least one month prior to study entry.
- 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 MP
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Drug: alpha-1 proteinase inhibitor (human)
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Primary Outcome(s)
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Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7
[Time Frame: Day 0 to Day 7]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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