Clinical Trial: Post Authorisation Safety Registry for US Patients With Generalised Lipodystrophy Treated With Metreleptin
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]
Official Title: Metreleptin Safety Registry
Brief Summary: Post Authorisation Safety Registry for US patients with Generalised Lipodystrophy treated with Metreleptin
Detailed Summary:
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.
Sponsor: Aegerion Pharmaceuticals, Inc.
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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)
Original Secondary Outcome: Same as current
Information By: Aegerion Pharmaceuticals, Inc.
Dates:
Date Received: December 22, 2014
Date Started: January 2016
Date Completion: October 2029
Last Updated: June 17, 2015
Last Verified: June 2015