Post Authorisation Safety Registry for US Patients With Generalised Lipodystrophy Treated With Metreleptin
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|ClinicalTrials.gov Identifier: NCT02325674|
Recruitment Status : Not yet recruiting
First Posted : December 25, 2014
Last Update Posted : June 18, 2015
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Metreleptin Safety Registry|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||October 2029|
|Estimated Study Completion Date :||October 2029|
Generalised lipodystrophy patients treated with Metreleptin
- Safety of multiple doses of Metreleptin in terms of adverse events incidence [ Time Frame: Adverse event will be collected from first dose to last visit - up to 15 years ]Estimation of the incidence rate of several adverse events in patients treated with metreleptin as part of current clinical practice.
- Characteristics of the study population in terms of demographic profile, vital signs and clinical signs [ Time Frame: Demographics and Vital Signs information will be collected at all study visits - up to 15 years ]Description of the overall demographic and clinical characteristics in all patients treated with metreleptin (pattern of use analysis)
- Characteristics of the study population in terms of clinical chemistry - Glycated Hemoglobin (HbA1c), Fasting Plasma Glucose (FPG) and Triglycerides (TG) [ Time Frame: Clinical chemistry will be collected at all study visits - up to 15 years ]Description of routine laboratory measurements that could be inferred as efficacy endpoints (including HbA1c, FPG, and TG) over time
- Characteristics of the study population in terms of its use of metreleptin [ Time Frame: Treatment information will be collected at all study visits - up to 15 years ]Description of the metreleptin exposure information in all patients treated with metreleptin (pattern of use analysis)
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): NCT02325674
|Contact: AstraZeneca Clinical Study Information Centeremail@example.com|
|United States, New York|
|Staten Island, New York, United States, 10314|
|Principal Investigator:||Katherine Tsai, MD, PhD||AstraZeneca|