Ignite Creation Date:
2024-05-06 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05227287
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2022-01-18
Brief Title:
ADH1 and ADH2 Disease Monitoring Study DMS
Sponsor:
Calcilytix Therapeutics Inc a BridgeBio company
Organization:
Calcilytix Therapeutics Inc a BridgeBio company
Study Overview
Official Title:
Autosomal Dominant Hypocalcemia Types 1 And 2 ADH12 Disease Monitoring Study DMS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
CLARIFY
Brief Summary:
A global multi-center Disease Monitoring Study DMS in participants with Autosomal Dominant Hypocalcemia Type 1 ADH1 or Autosomal Dominant Hypocalcemia Type 2 ADH2 designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective past and longitudinal prospective over time into the future data collection
Detailed Description:
The ADH1 and ADH2 DMS is designed to better understand the disease burden of ADH1 and ADH2 how participants with ADH1 or ADH2 are managed with standard of care practices in a real-world setting and how standard of care treatment impacts ADH1 and ADH2 symptoms
The study will include adult and pediatric participants with a confirmed clinical diagnosis of ADH1 or ADH2 Each participants data will be collected over a period of up to 5 years In addition retrospective or past data will be collected
The study will include adult and pediatric participants with a confirmed clinical diagnosis of ADH1 or ADH2 Each participants data will be collected over a period of up to 5 years In addition retrospective or past data will be collected
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