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

This study is currently recruiting participants.
Verified May 2013 by ViroPharma
Sponsor:
Information provided by (Responsible Party):
ViroPharma
ClinicalTrials.gov Identifier:
NCT01661387
First received: August 6, 2012
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Addison Disease
U.S. FDA Resources

Further study details as provided by ViroPharma:

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: 1000
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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661387

Contacts
Contact: Alexandra De Saedeleer +32 2 747 09 71 protocol-0918-400@viropharma.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
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
ViroPharma
Investigators
Study Director: Colin Broom, MD, MRCP ViroPharma
  More Information

No publications provided

Responsible Party: ViroPharma
ClinicalTrials.gov Identifier: NCT01661387     History of Changes
Other Study ID Numbers: Protocol 0918-400
Study First Received: August 6, 2012
Last Updated: May 2, 2013
Health Authority: United Kingdom: National Health Service
Germany: Ethics Commission
Sweden: Institutional Review Board
Sweden: Regional Ethical Review Board

Keywords provided by ViroPharma:
Adrenal insufficiency
Congenital adrenal hyperplasia (CAH)
Hydrocortisone
Modified release
DuoCort

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Hydrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013