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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Coram Clinical Trials
Sponsor:
Information provided by (Responsible Party):
Coram Clinical Trials
ClinicalTrials.gov Identifier:
NCT01974830
First received: October 21, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition
Alpha-1 Anti-trypsin Deficiency

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: AL1TER™: Alpha-1 Therapy, Evaluation, and Research Patient Registry

Resource links provided by NLM:


Further study details as provided by Coram Clinical Trials:

Primary Outcome Measures:
  • Change in Pulmonary Function [ Time Frame: From Baseline to 1 year ] [ Designated as safety issue: No ]
    Assessment of pulmonary function, including FEV1, at baseline and change (improvement or decline) at 1 year


Secondary Outcome Measures:
  • Change in Quality of Life [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]
    Patients will self complete 2 surveys, life quality index questionnaire (LQIQ) and the St. George Respiratory questionnaire that asses patients infusion experience, health improvement of infusions, pain, and cost of infusions, as well as the improvement or decline in patients perceptions of their lung and respiratory functions and activities related to that.

  • Pulmonary Infections and Exacerbation [ Time Frame: 6 months, 1 year, 2 years, 3 years. ] [ Designated as safety issue: No ]
    Number of pulmonary infections and exacerbation


Estimated Enrollment: 400
Study Start Date: October 2013
Estimated Study Completion Date: October 2025
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult Alpha-1 Patients
Adult Alpha-1 patients recieving augmentation therapy in the home through Coram

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974830

Contacts
Contact: Sean Kearns, Ph.D 303-672-8610 sean.kearns@coramhc.com
Contact: Loretta Kristofek, RN 321-206-3969 loretta.kristofek@coramhc.com

Locations
United States, Colorado
Coram Clinical Trials Recruiting
Denver, Colorado, United States, 80202
Contact: Sean Kearns, Ph.D    303-672-8610    sean.kearns@coramhc.com   
Contact: Loretta Kristofek, RN    321-206-3969    loretta.kristofek@coramhc.com   
Principal Investigator: D. Kyle Hogarth, MD         
Sponsors and Collaborators
Coram Clinical Trials
Investigators
Principal Investigator: D. Kyle Hogarth, MD University of Chicago, Dept. Pulmonology
  More Information

Additional Information:
No publications provided

Responsible Party: Coram Clinical Trials
ClinicalTrials.gov Identifier: NCT01974830     History of Changes
Other Study ID Numbers: CT-10-04
Study First Received: October 21, 2013
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Coram Clinical Trials:
alpha-1
anti-trypsin
pulmonary function
augmentation therayp
home care

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014