Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04580420
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2020-09-24
Brief Title:
Safety Efficacy of DCR-PHXC in Patients With PH12 and ESRD
Sponsor:
Dicerna Pharmaceuticals Inc a Novo Nordisk company
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of DCR-PHXC in Patients With Primary Hyperoxaluria Type 1 or 2 and Severe Renal Impairment With or Without Dialysis
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PHYOX7
Brief Summary:
The aim of this study is to evaluate DCR-PHXC in participants with PH1 or PH2 and severe renal impairment with or without dialysis
Detailed Description:
This is an open-label repeat-dose Phase 2 study of DCR-PHXC in participants with PH1 or PH2 and severe renal impairment with or without dialysis
Following the up-to-35- day screening period participants will return to the clinic for monthly dosing visits through Day 180 Participants successfully completing the Day 180 visit will continue on to an extended follow-up period and receive open-label DCR-PHXC for an additional 3 years or until DCR-PHXC is commercially available whichever comes first As participants in this extended treatment period will return to the clinic only every 3 months participants andor their caregivers may be trained in the at-home administration of DCR-PHXC or home health nurses may assist with administration of DCR -PHXC
The total duration of the study is approximately 2 years from first participant first visit to last participant last Day 180 visit with up to an additional 3 years of extended follow-up
Following the up-to-35- day screening period participants will return to the clinic for monthly dosing visits through Day 180 Participants successfully completing the Day 180 visit will continue on to an extended follow-up period and receive open-label DCR-PHXC for an additional 3 years or until DCR-PHXC is commercially available whichever comes first As participants in this extended treatment period will return to the clinic only every 3 months participants andor their caregivers may be trained in the at-home administration of DCR-PHXC or home health nurses may assist with administration of DCR -PHXC
The total duration of the study is approximately 2 years from first participant first visit to last participant last Day 180 visit with up to an additional 3 years of extended follow-up
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?:
None
Is an FDA AA801 Violation?:
None