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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01661387
First received: August 6, 2012
Last updated: June 15, 2016
Last verified: June 2016
  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:


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):
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
Hydrocortisone
Epinephrine
Racepinephrine
Epinephryl borate
Anti-Inflammatory Agents
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

ClinicalTrials.gov processed this record on September 28, 2016