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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01661387
Recruitment Status : Terminated (Takeda submitted 900 patient years Interim Analysis to PRAC and requested study to be closed since primary objective had been fulfilled. PRAC agreed and on 17Sep2020 approved closure of EU-AIR Registry. Takeda announced study closure on 31Oct2020.)
First Posted : August 9, 2012
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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Brief Summary:
As a post-approval requirement of the European Medicines Agency, this European patient post authorization safety study 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 or disease
Chronic Adrenal Insufficiency

Study Design
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Study Type : Observational
Actual Enrollment : 3258 participants
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 (AI)
Actual Study Start Date : August 7, 2012
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Plenadren
Modified release hydrocortisone
Other Glucocorticoid Replacement Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of intercurrent illness [ Time Frame: approximately 10 years ]
    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

  2. Incidence of adrenal crisis [ Time Frame: approximately 10 years ]
    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

  3. Incidence of serious adverse events [ Time Frame: approximately 10 years ]
    Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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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): NCT01661387


Locations
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Sponsors and Collaborators
Shire
Investigators
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Study Director: Shire Director Shire
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01661387    
Other Study ID Numbers: 0918-400
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Keywords provided by Takeda ( Shire ):
Adrenal insufficiency
DuoCort
Congenital adrenal hyperplasia (CAH)
Modified release
Hydrocortisone
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases