Ignite Creation Date:
2024-05-06 @ 1:31 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04042402
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-11
First Post:
2019-07-10
Brief Title:
Long Term Extension Study in Patients With Primary Hyperoxaluria
Sponsor:
Dicerna Pharmaceuticals Inc a Novo Nordisk company
Organization:
Novo Nordisk AS
Study Overview
Official Title:
An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection Subcutaneous Use in Patients With Primary Hyperoxaluria
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
PHYOX3
Brief Summary:
The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings 18 years old long-term access to DCR-PHXC and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None