Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524726
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
The International PNH Interest Group PNH Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The International PNH Interest Group PNH Registry
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this International PNH Interest Group IPIG registry is to develop an international database to prospectively collect data on patients with PNH covering clinical outcomes patient reported outcomes PROs and health-resource utilization HRU on all enrolled patients as well as long term safety data
Detailed Description:
The International PNH Interest Group IPIG PNH Registry is an international observational database collecting real-world health information about PNH patients over time The registry is owned and managed by IPIG a not-for-profit network of international PNH experts dedicated to improving care and treatment for PNH patients Several pharmaceutical partners are collaborating with IPIG to fund the registry which will provide data to support their post-approval regulatory commitments
The IPIG PNH Registry aims to collect data about all PNH patients including clinical outcomes patient reported outcomes and health resource usage as well as long term safety data for patients treated with anti-complement therapies
The IPIG PNH Registry is comprised of a core PNH disease registry collecting a defined set of core variables on all patients with PNH In addition there are several product-specific silos initiated by marketing authorization holders including patients treated with PNH-specific therapies The silos collect both the core dataset and additional variables to address specific objectives or requests from regulatory authorities eg post-authorization safety data
Data is collected at enrollment and at 6 monthly intervals during follow-up
This clinical trial information was submitted voluntarily under the applicable law and therefore certain submission deadlines may not apply That is clinical trial information for this applicable clinical trial was submitted under section 402j4A of the Public Health Service Act and 42 CFR 1160 and is not subject to the deadlines established by sections 402j2 and 3 of the Public Health Service Act or 42 CFR 1124 and 1144
The IPIG PNH Registry aims to collect data about all PNH patients including clinical outcomes patient reported outcomes and health resource usage as well as long term safety data for patients treated with anti-complement therapies
The IPIG PNH Registry is comprised of a core PNH disease registry collecting a defined set of core variables on all patients with PNH In addition there are several product-specific silos initiated by marketing authorization holders including patients treated with PNH-specific therapies The silos collect both the core dataset and additional variables to address specific objectives or requests from regulatory authorities eg post-authorization safety data
Data is collected at enrollment and at 6 monthly intervals during follow-up
This clinical trial information was submitted voluntarily under the applicable law and therefore certain submission deadlines may not apply That is clinical trial information for this applicable clinical trial was submitted under section 402j4A of the Public Health Service Act and 42 CFR 1160 and is not subject to the deadlines established by sections 402j2 and 3 of the Public Health Service Act or 42 CFR 1124 and 1144
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None