Brief Title
An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy
Official Title
An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy
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 investigators with respect to identification of appropriate subjects for
metreleptin treatment, guidance on metreleptin dosing, and collection of safety and efficacy
data following metreleptin treatment in this population
Study Type
Interventional
Primary Outcome
To provide metreleptin, an investigational medication, under a treatment protocol to subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia
Secondary Outcome
To monitor the safety and tolerability of metreleptin in subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia
Condition
Lipodystrophy
Intervention
metreleptin
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
41
Start Date
March 2009
Completion Date
January 2015
Primary Completion Date
January 2015
Eligibility Criteria
Inclusion Criteria:
- Is male or female ≥5 years old
- If female of childbearing potential (including perimenopausal women who have had a
menstrual period within one year):
1. Not breastfeeding
2. Negative pregnancy test result
3. 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:
1. Diabetes Mellitus
2. 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 Criteria:
- 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
Gender
All
Ages
5 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bristol-Myers Squibb, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00677313
Organization ID
MB002-002
Secondary IDs
FHA101
Responsible Party
Sponsor
Study Sponsor
Bristol-Myers Squibb
Study Sponsor
Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
Verification Date
February 2015