We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified April 2017 by Coram Clinical Trials
Sponsor:
ClinicalTrials.gov Identifier:
NCT01974830
First Posted: November 4, 2013
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Coram Clinical Trials
  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 ]
    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 ]
    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. ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974830


Contacts
Contact: L. Allyson Checkley, PhD 303-672-8888 laura.checkley@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: L. Allyson Checkley, PhD    303-672-8888    laura.checkley@coramhc.com   
Contact: Loretta Kristofek, RN    321-206-3969    loretta.kristofek@coramhc.com   
Principal Investigator: Donald Schmechel, MD         
Sponsors and Collaborators
Coram Clinical Trials
Investigators
Principal Investigator: Donald Schmechel, MD Southeast Neurology and Memory Clinic
  More Information

Additional Information:
Responsible Party: Coram Clinical Trials
ClinicalTrials.gov Identifier: NCT01974830     History of Changes
Other Study ID Numbers: CT-10-04
First Submitted: October 21, 2013
First Posted: November 4, 2013
Last Update Posted: April 25, 2017
Last Verified: April 2017

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