NCT03039335

Brief Summary

The objective of this study is to prospectively assess whether there is any interval between first symptom and initial diagnosis that is experienced by patients with newly diagnosed alpha-1 antitrypsin deficiency (AATD) and then to assess whether this diagnostic interval is associated with worsened clinical status at the time of initial diagnosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2018

Completed
Last Updated

July 16, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

January 31, 2017

Last Update Submit

July 13, 2018

Conditions

Alpha 1-Antitrypsin Deficiency

Outcome Measures

Primary Outcomes (1)

  • Recruitment

    Track the number of subjects enrolled to determine if recruitment strategies need to be altered.

    3 months

Study Arms (1)

Adults with an AAT Deficiency

Subjects over the age of 18 that have been recently diagnosed with an Alpha-1 Antitrypsin deficiency will be enrolled into the study to observe the interval between first symptom and initial diagnosis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AATD Positive Adult Subjects

You may qualify if:

  • years of age or older
  • Positive AATD Test Result

You may not qualify if:

  • Previous Positive AATD Test Result
  • Negative Test Result for AATD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biocerna LLC

Fulton, Maryland, 20759, United States

Location

MeSH Terms

Conditions

alpha 1-Antitrypsin Deficiency

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubcutaneous EmphysemaEmphysemaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher Sanders

    CEO of Biocerna LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 1, 2017

Study Start

December 15, 2016

Primary Completion

April 15, 2018

Study Completion

April 15, 2018

Last Updated

July 16, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)