Status:
COMPLETED
An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Lipodystrophy
Eligibility:
All Genders
5+ years
Phase:
NA
Brief Summary
This is an open-label study to provide metreleptin for the treatment of diabetes mellitus and/or hypertriglyceridemia associated with lipodystrophy. This study intends to provide guidance to investiga...
Eligibility Criteria
Inclusion
- Is male or female ≥5 years old
- If female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):
- Not breastfeeding
- Negative pregnancy test result
- Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of the study (Double barrier methods including the use of female diaphragm and male condom with spermicide can also be used.)
- Has physician-confirmed lipodystrophy as defined by evidence of generalized (whole body) or partial (limbs) loss of body fat outside the range of normal variation
- Has been diagnosed with at least one of the following 2 metabolic disorders:
- Diabetes Mellitus
- Hypertriglyceridemia as defined by fasting triglyceride concentrations \>200 mg/dL
- If ≥18 years of age, is able to read, understand, and sign the Informed Consent Form (ICF) and an Authorization to Use and Disclose Protected Health Information form, communicate with the investigator, and understand and comply with protocol requirements
- If \<18 years of age, has a parent or legal guardian to read and understand the ICF and Child Assent Form, communicate with the investigator, and understand and comply with protocol requirements. Adolescent subjects must also read and understand the Child Assent Form; if the child is too young or unable to read, then the Child Assent Form must be explained to the child.
Exclusion
- Has been diagnosed with HIV infection
- Has known infectious liver disease
- Has known allergies to E. coli-derived proteins or hypersensitivity to any component of study treatment
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00677313
Start Date
March 1 2009
End Date
January 1 2015
Last Update
April 30 2015
Active Locations (5)
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1
Research Site
Santa Barbara, California, United States
2
Research Site
Chicago, Illinois, United States
3
Research Site
Ann Arbor, Michigan, United States
4
Local Institution
Reno, Nevada, United States, 89502