Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02426775
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2015-04-22
Brief Title:
Carglumic Acid in Methylmalonic Acidemia and Propionic Acidemia
Sponsor:
King Abdullah International Medical Research Center
Organization:
King Abdullah International Medical Research Center
Study Overview
Official Title:
Randomized Multicentre Comparative Trial to Evaluate the Long Term Effectiveness of the Use of Carbaglu in Patients With Propionic Acidemia PA or Methylmalonic Acidemia MMA
Status:
COMPLETED
Status Verified Date:
2019-04
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:
CAMP
Brief Summary:
A Phase IIIb Three b Randomized Multicentre Comparative Trial to Evaluate the Long Term Effectiveness Safety of the use of Carglumic Acid Carbaglu in Patients with Propionic Acidemia PA or Methylmalonic Acidemia MMA Carbaglu clinical experience in Organic Acidemia OA is limited to a non-comparative retrospective collection of data from patients who had received Carbaglu for 1 to 15 days
There is no current evidence supporting the use of carglumic acid for the chronic management of patients with OA The investigators are proposing a randomized multicentre prospective clinical trial to evaluate long-term effects of the use of Carbaglu 50mgkgday combined with standard chronic therapy in patients with PA and MMA compared to standard chronic therapy alone
There is no current evidence supporting the use of carglumic acid for the chronic management of patients with OA The investigators are proposing a randomized multicentre prospective clinical trial to evaluate long-term effects of the use of Carbaglu 50mgkgday combined with standard chronic therapy in patients with PA and MMA compared to standard chronic therapy alone
Detailed Description:
None
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