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AL1TER — A Landmark Patient Registry Program

The Alpha-1 Therapy, Evaluation, and Research (AL1TER) Patient Registry Program will serve as a platform for epidemiological analyses as well as the development of new therapeutic and treatment care strategies for the Alpha-1 population.

Coram Clinical Trials is proud to sponsor the AL1TER Patient Registry Program.

The AL1TER Patient Registry Program will fill an important niche between formal clinical trials and real-world clinical practice, helping to provide an accurate view of the current treatment space.

About the AL1TER Patient Registry

The Alpha-1 Therapy, Evaluation, and Research (AL1TER) Registry is a longitudinal, observational registry for patients diagnosed with Alpha-1 Antitrypsin Deficiency (Alpha-1) who are receiving Alpha-1 Antitrypsin (AAT) augmentation therapy in the home. This deliberate and purposeful assembly of clinical and humanistic knowledge is intended to collect and analyze data related to Alpha-1, especially factors related to initial diagnosis and treatment outcomes.

The Registry's goal is to significantly contribute to the medical understanding of Alpha-1 and to improve the quality of care for patients receiving Alpha-1 augmentation therapy in the U.S. through active publication of Registry findings and disease management approaches.

The AL1TER Registry program represents a unique and powerful method for the collection of:

  • Patient-level data: humanistic information addressing quality of life
  • Physician-level data: practice patterns
  • Clinical data: therapeutic outcomes
  • Reimbursement data: impact on treatment and policy decisions

The AL1TER Registry can help to:

  • Accelerate innovation,
  • Produce faster knowledge gai,n
  • Improve awareness of patient outcomes and disease burden, and
  • Provide a clearer understanding of therapy impact on the patients' quality of life.

Registry Objectives

  • Enhance the understanding of the initial presenation, variability, and progressionof Alpha-1 with the ultimate goal of better guiding and assessing therapeutic intervention;
  • Provide the Alpha-1 medical community with recommendations for monitoring patients and to provide reports on patient outcomes to help optimize patient care;
  • Serve as an active knowledge base that can provide population-management information, which can be used to generate patient-management and practice-management tools; and
  • Add to the existing body of knowledge through peer-reviewed manuscripts, scientific abstracts and posters, medical symposia presentation, and patient education.

This study has been registered with in accordance with the Food and Drug Administration Amendments Act of 2007.

  • View details of the AL1TER Patient Registry on

How to Participate

We are actively seeking physicians to participate as sub-investigators in this landmark patient registry. All physicians who screen for Alpha-1, as well as treat Alpha-1 patients, are encouraged to participate.

Physician and patient participation is completely voluntary and can be terminated
at any time.

The Registry is observational in nature; no change to a patient's medical care is required for participation. Subjects in the Registry will be contacted approximately every six months to complete various quality-of-life scales.

Thank you for your interest in the AL1TER Patient Registry Program.

Registry Criteria

Patient registries collect data in a comprehensive manner, and therefore produce outcome results that can be generalized to a wide range of patients. They also evaluate care as it is actually provided, because care is not assigned, determined, or even recommended by a protocol. As a result, the outcomes reported are more representative of what is achieved in real-world practice.

A patient registry can be a powerful tool: to observe the course of disease; to understand variations in treatment and outcomes; to examine factors that influence prognosis and quality of life; to describe care patterns, including appropriateness of care and disparities in the delivery of care; to assess effectiveness of care; to monitor safety; and to change behavior through feedback of data.

Inclusion Criteria for Patients

  • Patient is currently receiving Alpha-1 augmentation therapy
  • Patient agrees to participate in the Registry
  • Patient is on service and receiving care with Coram

Exclusion Criteria for Patients

  • Patient withdraws their participation consent
  • Patient stops service with Coram



AL1TER Patient Registry Program
Toll-Free: 800.589.9589
Fax: 949.597.2653
Sean Kearns, PhD
Registry Program Manager
Phone: 303.672.8610
Loretta Kristofek
Registry Manager
Phone: 321.206.3969



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