Brief Title
The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
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
Brief Summary
The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in
adult Alpha1-antitrypsin deficient patients.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Treatment-emergent Adverse Events (TEAEs) Defined as Any Adverse Event (AE) Occurring During or After the Start of the First Study Drug Infusion.
Condition
Alpha 1-Antitrypsin Deficiency
Intervention
alpha-1 proteinase inhibitor (human)
Study Arms / Comparison Groups
Alpha-1 Proteinase Inhibitor (Human), modified process
Description: Study the safety and tolerability of weekly infusions of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP, 60 mg/kg) over 20 weeks of therapy in adult Alpha-1 antitrypsin deficient subjects.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
38
Start Date
June 2006
Completion Date
March 2007
Primary Completion Date
March 2007
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Kim Hanna, MSc, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT00301366
Organization ID
11815
Responsible Party
Sponsor
Study Sponsor
Grifols Therapeutics LLC
Study Sponsor
Kim Hanna, MSc, Study Director, Grifols Therapeutics LLC
Verification Date
July 2014