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

Information source: Grifols Therapeutics Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alpha 1-Antitrypsin Deficiency

Intervention: alpha-1 proteinase inhibitor (human) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Grifols Therapeutics Inc.

Official(s) and/or principal investigator(s):
Kim Hanna, MSc, Study Director, Affiliation: Grifols Therapeutics Inc.

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

National Jewish Medical and Research Center, Denver, Colorado 80206, United States

University of Cambridge - Cambridge Institute for Medical Research, Cambridge, England CB2 2XY, United Kingdom

University of Florida College of Medicine, Gainesville, Florida 32610-0225, United States

University of Miami School of Medicine, Miami, Florida 33101, United States

St Lukes-Roosevelt Hospital Center, New York, New York, New York 10019, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44122, United States

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

University Teaching Hospital of Edinburgh, Edinburgh, Scotland EH8 9AG, United Kingdom

Medical University of South Carolina, Charleston, South Carolina 29425, United States

University of Texas Health Center at Tyler, Tyler, Texas 75708-3154, United States

Additional Information

The "Alpha-1 Foundation", dedicated to providing the leadership and resources that will result in increased research, improved health, worldwide detection and a cure for Alpha-1 Antitrypsin Deficiency

AlphaNet, Inc devoted to improving the lives of individuals with Alpha-1 antitrypsin deficiency through comprehensive disease management services, clinical research administration, and consultative services

Related publications:

Wewers MD, Casolaro MA, Sellers SE, Swayze SC, McPhaul KM, Wittes JT, Crystal RG. Replacement therapy for alpha 1-antitrypsin deficiency associated with emphysema. N Engl J Med. 1987 Apr 23;316(17):1055-62.

Gadek JE, Klein HG, Holland PV, Crystal RG. Replacement therapy of alpha 1-antitrypsin deficiency. Reversal of protease-antiprotease imbalance within the alveolar structures of PiZ subjects. J Clin Invest. 1981 Nov;68(5):1158-65.

Gadek JE, Fells GA, Zimmerman RL, Rennard SI, Crystal RG. Antielastases of the human alveolar structures. Implications for the protease-antiprotease theory of emphysema. J Clin Invest. 1981 Oct;68(4):889-98.

Starting date: June 2006
Last updated: July 30, 2014

Page last updated: August 23, 2015

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