Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05762445
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2022-01-20
Brief Title:
PAtient-CenTric Chronic Pancreatitis Registry PACT-CP
Sponsor:
CorEvitas
Organization:
CorEvitas
Study Overview
Official Title:
A Patient-Driven Registry for Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
PACT-CP
Brief Summary:
The main objective of this study is to generate real-world evidence reflecting the experience of individuals with exocrine pancreatic insufficiency EPI due to chronic pancreatitis CP Efforts will be directed toward understanding the unmet need and therapeutic burden to identify the most critical factors that influence treatment choicesprescribing patterns quality of life and healthcare utilization outcomes in standard of care for individuals with EPI due to CP
Detailed Description:
Study participants will be followed prospectively and data from study participants will be collected at 3-month intervals via Electronic Data Capture EDC portal Investigators will complete assessments approximately every 6 months at the time of routine clinical encounters Adverse Events AEs will be collected as part of the study data collection forms Serious Adverse Events SAEs are to be reported within 24 hours 1 business day of awareness whether or not the site learns of the event at the time of a registry follow-up visit
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?:
False
Is an FDA AA801 Violation?:
None