Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03621007
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2018-07-30
Brief Title:
An ObservationalProspective Natural History Study of Early-Onset Extreme Obesity Due to Bi-Allelic Loss-of-Function Mutations in the POMC PCSK1 or LEPR Genes
Sponsor:
Rhythm Pharmaceuticals Inc
Organization:
Rhythm Pharmaceuticals Inc
Study Overview
Official Title:
An ObservationalProspective Natural History Study of Early-Onset Extreme Obesity Due to Bi-Allelic Loss-of-Function Mutations in the POMC PCSK1 or LEPR Genes
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NHS
Brief Summary:
This is an observational study There are no protocol-defined visits although patients are expected to have routine office visits approximately every 6 months Upon signing of informed consentassent and study enrollment historical data will be abstracted from the patients medical chart The patient will then be observed prospectively for up to 5 years with additional data collected from routine healthcare encounters and direct-to-patient questionnaires where local laws allow including laboratory tests physical exam and patient reported outcomesquality of life measures Patients will be consentedassented to provide blood samples for biomarker assessments DNA sequencing and archiving
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None