Phase 3 Completed N=38 Treatment

The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency

Source: ClinicalTrials.gov NCT00301366 ↗

Enrolled (actual)

Serious AEs

5.3%

Results posted

Aug 2014

Primary outcomePrimary: 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

Summary

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

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.