Phase 3
N=38
The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
Alpha 1-Antitrypsin Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT00301366 ↗Enrolled (actual)
38
Serious AEs
5.3%
Results posted
Aug 2014
Primary outcome: Primary: Treatment-emergent Adverse Events (TEAEs) Defined as Any Adverse Event (AE) Occurring During or After the Start of the First Study Drug Infusion. — 38; 26; 17; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- alpha-1 proteinase inhibitor (human) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grifols Therapeutics LLC
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-emergent Adverse Events (TEAEs) Defined as Any Adverse Event (AE) Occurring During or After the Start of the First Study Drug Infusion. |
38; 26; 17; 5 | — |
Summary
The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.
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
Data sourced from ClinicalTrials.gov (NCT00301366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.