AL1TER™: Alpha-1 Therapy, Evaluation, and Research Patient Registry

NCT01974830 | Completed

• 1 other identifier: CT-10-04
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a longitudinal, observational, non-interventional registry study, designed to collect both retrospective and prospective real world data, on patients receiving Alpha-1 augmentation therapy in the home through Coram Specialty Infusion.The data will be collected from standard Coram homecare forms, as well as patient reported case forms.

Conditions

Alpha-1 Anti-trypsin Deficiency

Keywords

alpha-1; anti-trypsin; pulmonary function; augmentation therayp; home care

Outcome Measures

Primary Outcomes (1)

• Change in Pulmonary Function

  Assessment of pulmonary function, including FEV1, at baseline and change (improvement or decline) at 1 year

  From Baseline to 1 year

Secondary Outcomes (2)

• Change in Quality of Life

  Baseline and 6 month

• Pulmonary Infections and Exacerbation

  6 months, 1 year, 2 years, 3 years.

Study Arms (1)

Adult Alpha-1 Patients

Adult Alpha-1 patients receiving augmentation therapy in the home through Coram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with Alpha-1 anti-trypsin deficiency (any phenotype) on augmentation therapy

You may qualify if:

• Patients must meet the following criteria to participate in this study:
• Signed informed consent Either male or female, ≥18yrs of age requiring α1-PI therapy Agree to the use of Coram's infusion services upon entry into AL1TER Registry

You may not qualify if:

• Patients will be excluded from participation in the study for any of the following reasons:
• Currently using an insurance provider for which Coram's services are not covered/authorized Have previously participated in the AL1TER Registry and revoked consent to the use of their Protected Health Information in theAL1TER Registry database Under the age of 18, or member of a vulnerable population (prisoner, unable to understand the English version of the consent, or unable to sign consent themselves)

Sponsors & Collaborators

• Coram Clinical Trials: lead

Study Sites (1)

Coram Clinical Trials

Centennial, Colorado, 80112, United States

Location

MeSH Terms

Conditions

alpha 1-Antitrypsin Deficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald Schmechel, MD

  Southeast Neurology and Memory Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: November 4, 2013
• Study Start: October 1, 2013
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

US (1)