The Safety and Tolerability of Alpha-1 MP In Subjects With Alpha-1-Antitrypsin (AAT) Deficiency - Tabular View

Tracking Information

First Received Date ^ICMJE

March 8, 2006

Last Updated Date

September 26, 2008

Start Date ^ICMJE

May 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

treatment-emergent adverse events [ Time Frame: 24 weeks ]

Original Primary Outcome Measures ^ICMJE

Description of reported adverse events and all treatment-emergent adverse events as well as treatment-emergent drug-related adverse events

Change History

Complete list of historical versions of study NCT00301366 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

all adverse events [ Time Frame: 24 weeks ]
Laboratory data outside normal range [ Time Frame: 24 weeks ]

Original Secondary Outcome Measures ^ICMJE

Vital signs
Laboratory data outside normal range

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Alpha 1-Antitrypsin Deficiency

Intervention ^ICMJE

Drug: alpha-1 proteinase inhibitor (human)

Study Arms / Comparison Groups

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Documented diagnosis of congenital Alpha1-antitrypsin deficiency
Documented 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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Poland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00301366

Responsible Party

Study ID Numbers ^ICMJE

11815

Study Sponsor ^ICMJE

Talecris Biotherapeutics

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Eric Batson, MD

Talecris Biotherapeutics

Information Provided By

Talecris Biotherapeutics

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP