Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02262832
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Age greater than or equal to 6 months.
2. Generalized lipodystrophy (either congenital or acquired).
3. Those who cannot obtain metreleptin through approved or compassionate use mechanisms in their home country.
EXCLUSION CRITERIA:
1. Availability of metreleptin to the patient either as an approved drug, or through local compassionate use or expanded access programs.
2. Known HIV infection or HIV-associated lipodystrophy.
3. Any medical condition or medication that will increase risk to the subject.
4. Current alcohol or substance abuse.
5. Subjects who have a known hypersensitivity to E. coli derived proteins (as leptin is derived from such proteins).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
98 Years
Study:
NCT02262832
Study Brief:
Protocol Section:
NCT02262832