Post Authorisation Safety Registry for US Patients With Generalised Lipodystrophy Treated With Metreleptin
Information source: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalised Lipodystrophy
Phase: N/A
Status: Not yet recruiting
Sponsored by: Aegerion Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
Katherine Tsai, MD, PhD, Principal Investigator, Affiliation: AstraZeneca
Overall contact:
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
Summary
Post Authorisation Safety Registry for US patients with Generalised Lipodystrophy treated
with Metreleptin
Clinical Details
Official title: Metreleptin Safety Registry
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Safety of multiple doses of Metreleptin in terms of adverse events incidence
Secondary outcome: Characteristics of the study population in terms of demographic profile, vital signs and clinical signsCharacteristics of the study population in terms of clinical chemistry - Glycated Hemoglobin (HbA1c), Fasting Plasma Glucose (FPG) and Triglycerides (TG) Characteristics of the study population in terms of its use of metreleptin
Detailed description:
Post Authorisation Safety Registry for US patients with Generalised Lipodystrophy treated
with Metreleptin.
This registry will add to the knowledge about metreleptin gained from clinical trials by
providing information on the incidence rates of acute pancreatitis, hypoglycemia,
hypersensitivity and lymphoma in patients treated with metreleptin in routine clinical
practice.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who are treated with metreleptin as part of clinical care
- Patients who provide a written consent
Exclusion Criteria:
- Patient receiving metreleptin as part of a clinical trial or through expended access
including compassionate use
- Patients currently treated with an investigational agent as part of a clinical trial
Locations and Contacts
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
Research Centre, Staten Island, New York 10314, United States; Not yet recruiting
Additional Information
Starting date: January 2016
Last updated: June 17, 2015
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