A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency - Full Text View

Purpose

As a post-approval requirement of the European Medicines Agency, this European patient registry is an observational study being conducted to monitor the safety of long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).

Condition
Chronic Adrenal Insufficiency


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency

Resource links provided by NLM:

Genetics Home Reference related topics: congenital adrenal hyperplasia due to 11-beta-hydroxylase deficiency familial glucocorticoid deficiency

Drug Information available for: Hydrocortisone Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine

Genetic and Rare Diseases Information Center resources: Hypoadrenalism 21-hydroxylase Deficiency Congenital Adrenal Hyperplasia

U.S. FDA Resources

Further study details as provided by Shire:

Primary Outcome Measures:

Incidence of intercurrent illness [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Incidence of adrenal crisis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Incidence of serious adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	1656
Study Start Date:	August 2012
Estimated Primary Completion Date:	August 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts
Plenadren Modified release hydrocortisone
Other Glucocorticoid Replacement Therapy

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with chronic adrenal insufficiency (primary or secondary) who are receiving Plenadren or other glucocorticoid replacement therapies at endocrinology centres in certain European countries as part of their routine clinical care. Approximately 20 sites are planned for enrollment.

Criteria

Inclusion Criteria:

Diagnosis of chronic adrenal insufficiency
Written informed consent/assent in compliance with applicable country-specific and local regulations

Exclusion Criteria:

Participation in an interventional clinical trial

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: NCT01661387

Contacts


Contact: Shire Contact		protocol0918400@shire.com
Contact: Shire Transparency		clinicaltransparency@shire.com

Locations


Germany
ViroPharma Investigational Site	Recruiting
Berlin, Germany
ViroPharma Investigational Site	Recruiting
Erlangen, Germany
ViroPharma Investigational Site	Recruiting
Frankfurt, Germany
ViroPharma Investigational Site	Recruiting
Munich, Germany
ViroPharma Investigational Site	Recruiting
Wuerzburg, Germany
Netherlands
ViroPharma Investigational Site	Recruiting
Groningen, Netherlands
ViroPharma Investigational Site	Recruiting
Rotterdam, Netherlands
ViroPharma Investigational Site	Recruiting
Utrecht, Netherlands
Sweden
ViroPharma Investigational Site	Recruiting
Gothenburg, Sweden
ViroPharma Investigational Site	Recruiting
Linkoping, Sweden
United Kingdom
ViroPharma Investigational Site	Recruiting
Birmingham, United Kingdom
ViroPharma Investigational Site	Recruiting
Leeds, United Kingdom
ViroPharma Investigational Site	Recruiting
London, United Kingdom
ViroPharma Investigational Site	Recruiting
Manchester, United Kingdom
ViroPharma Investigational Site	Recruiting
Newcastle, United Kingdom
ViroPharma Investigational Site	Recruiting
Oxford, United Kingdom

Sponsors and Collaborators

Shire

Investigators


Study Director:	Shire Study Physician	Shire

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ekman B, Fitts D, Marelli C, Murray RD, Quinkler M, Zelissen PM. European Adrenal Insufficiency Registry (EU-AIR): a comparative observational study of glucocorticoid replacement therapy. BMC Endocr Disord. 2014 May 9;14:40. doi: 10.1186/1472-6823-14-40.


Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01661387 History of Changes
Other Study ID Numbers:	Protocol 0918-400
Study First Received:	August 6, 2012
Last Updated:	June 15, 2016
Health Authority:	Sweden: Institutional Review Board United Kingdom: National Health Service Germany: Ethics Commission Sweden: Regional Ethical Review Board

Keywords provided by Shire:


Adrenal insufficiency DuoCort Congenital adrenal hyperplasia (CAH) Modified release Hydrocortisone

Additional relevant MeSH terms:


Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Epinephrine Racepinephrine Epinephryl borate Hydrocortisone Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action	Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 30, 2016