Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-06 @ 1:48 AM
Study NCT ID:
NCT02246894
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
Sponsor:
Bio Products Laboratory
Organization:
Study Overview
Official Title:
An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.
Status:
COMPLETED
Status Verified Date:
2018-02
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:
None
Brief Summary:
The main objectives of this study are:
* to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
* to assess clinical outcome when treating a bleed with Optivate®.
* to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
* to assess FVIII inhibitor development during the study.
* to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
* to assess clinical outcome when treating a bleed with Optivate®.
* to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
* to assess FVIII inhibitor development during the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: