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EARCO REGISTRY. History Of Patients With Alpha-1 Antitrypsin

NCT04180319 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2020-02-07

No results posted yet for this study

Summary

European Alpha-1 Research Collaboration (EARCO) is a pan-European network committed to promoting clinical research and education in alpha-1 antitrypsin deficiency (AATD). The core project is the pan-European AATD Registry, a collaboration which will offer longitudinal real-world data for patients with AATD. EARCO has a global vision to increase the early diagnosis of alpha-1 antitrypsin deficiency (AATD), understand better the natural history of the disease and ensure optimal access to effective care, placing emphasis on ambitions that serve collective needs of the AATD research community and bringing people with AAT deficiency to the centre of the research environment in a real-world context.

The study population will consist of individuals with diagnosed severe alpha-1 antitrypsin deficiency regardless of the clinical expression and severity.

The study objectives are:

* To generate long-term, high-quality clinical data covering a pan-European population of AATD individuals in all age groups and all stages of disease severity.
* To understand the natural history and prognosis of AATD better with the goal to create and validate prognostic tools to support medical decision making.
* To investigate the effect of augmentation therapy on the progression of emphysema and to examine its impact on clinical and functional outcomes, such as FEV1, quality of life and mortality in a "real-life" population
* To learn more about the course of the disease in patients suffering from severe AATD with genotypes different from Pi\*ZZ We expect to collect detailed information from around 1,000 patients from at least 10 countries during the first year, expanding to 3,000 from more than 25 countries over the 5 years of the CRC and continue a long term follow-up.

We expect to collect detailed information from around 1,000 patients from at least 10 countries during the first year, expanding to 3,000 from more than 25 countries over the 5 years of the CRC and continue a long term follow-up. .

Conditions

Sponsors & Collaborators

  • European Respiratory Society

    collaborator OTHER

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • MARC MIRAVITLLES, MD-PhD · Hospital Vall d'Hebron

  • Timm Greulich, MD-PhD · University Medical Centre Giessen and Marburg, Germany

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2021-02-05
Completion
2025-02-05

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04180319 on ClinicalTrials.gov