Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04654468
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2020-11-30
Brief Title:
A Study Evaluating the Efficacy Safety Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria PNH Not Previously Treated With Complement Inhibition
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase III Multicenter Single Arm Study Evaluating the Efficacy Safety Pharmacokinetics and Pharmacodynamics of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria PNH Not Previously Treated With Complement Inhibition
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
COMMODORE 3
Brief Summary:
This study will enrol participants aged 12 years or older with a body weight 40 kilograms kg diagnosed with PNH who have not been previously treated with complement inhibitor therapy Approximately 50 participants will be treated with Crovalimab for at least 24 weeks
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