Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post Authorisation Safety Registry for US Patients With Generalised Lipodystrophy Treated With Metreleptin

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02325674
Recruitment Status : Not yet recruiting
First Posted : December 25, 2014
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Brief Summary:
Post Authorisation Safety Registry for US patients with Generalised Lipodystrophy treated with Metreleptin

Condition or disease
Generalised Lipodystrophy

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Metreleptin

Group/Cohort
Metreleptin
Generalised lipodystrophy patients treated with Metreleptin



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 Generalised Lipodystrophy treated with Metreleptin
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

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): NCT02325674


Contacts
Layout table for location contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Layout table for location information
United States, New York
Research Centre Not yet recruiting
Staten Island, New York, United States, 10314
Sponsors and Collaborators
Aegerion Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Katherine Tsai, MD, PhD AstraZeneca

Additional Information:

Layout table for additonal information
Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02325674     History of Changes
Other Study ID Numbers: D5560R00003
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015
Keywords provided by Aegerion Pharmaceuticals, Inc.:
Lipodystrophy
Metreleptin Registry
Additional relevant MeSH terms:
Layout table for MeSH terms
Lipodystrophy, Congenital Generalized
Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn