Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125541
Status:
COMPLETED
Last Update Posted:
2009-05-04
First Post:
2005-07-29
Brief Title:
C1-Esteraseremmer-N for the Treatment of Hereditary and Acquired Angioedema
Sponsor:
Prothya Biosolutions
Organization:
Prothya Biosolutions
Study Overview
Official Title:
Pharmacokinetics Clinical Efficacy and Safety of C1 Inhibitor Concentrate C1-Esteraseremmer-N for the Treatment of Hereditary and Acquired Angioedema
Status:
COMPLETED
Status Verified Date:
2009-05
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:
A multicentre study to investigate the pharmacokinetics clinical efficacy and safety of nanofiltered Cetor called C1-esteraseremmer-N during the development phase for the treatment of hereditary angioedema HAE will be performed This study KB200301 consists of three parts Part A - pharmacokinetics phase II Part B - treatment of attacks of angioedema phase III and Part C - prophylactic use of C1 inhibitor phase III Parts B C will provide data on the efficacy of C1-esteraseremmer-N
The changes within the manufacturing process of C1-esteraseremmer-N compared to Cetor nanofiltration and omission of hepatitis B immunoglobulin most likely will not affect tolerability The nanofiltration will provide more safety regarding viruses
In part C of the study a number of HAE patients will be treated prophylactically with open-label C1-esteraseremmer-N for a period of 16 weeks The number of attacks occurring will be compared with historical data If possible also some patients treated prophylactically with C1 inhibitor for acquired angioedema will be included
The changes within the manufacturing process of C1-esteraseremmer-N compared to Cetor nanofiltration and omission of hepatitis B immunoglobulin most likely will not affect tolerability The nanofiltration will provide more safety regarding viruses
In part C of the study a number of HAE patients will be treated prophylactically with open-label C1-esteraseremmer-N for a period of 16 weeks The number of attacks occurring will be compared with historical data If possible also some patients treated prophylactically with C1 inhibitor for acquired angioedema will be included
Detailed Description:
A multicentre study to investigate the pharmacokinetics clinical efficacy and safety of nanofiltered Cetor called C1-esteraseremmer-N during the development phase for the treatment of hereditary angioedema HAE will be performed This study KB200301 consists of three parts Part A - pharmacokinetics phase II Part B - treatment of attacks of angioedema phase III and Part C - prophylactic use of C1 inhibitor phase III Parts B C will provide data on the efficacy of C1-esteraseremmer-N
The changes within the manufacturing process of C1-esteraseremmer-N compared to Cetor nanofiltration and omission of hepatitis B immunoglobulin most likely will not affect tolerability The nanofiltration will provide more safety regarding viruses
In part C of the study a number of HAE patients will be treated prophylactically with open-label C1-esteraseremmer-N for a period of 16 weeks The number of attacks occurring will be compared with historical data If possible also some patients treated prophylactically with C1 inhibitor for acquired angioedema will be included
The changes within the manufacturing process of C1-esteraseremmer-N compared to Cetor nanofiltration and omission of hepatitis B immunoglobulin most likely will not affect tolerability The nanofiltration will provide more safety regarding viruses
In part C of the study a number of HAE patients will be treated prophylactically with open-label C1-esteraseremmer-N for a period of 16 weeks The number of attacks occurring will be compared with historical data If possible also some patients treated prophylactically with C1 inhibitor for acquired angioedema will be included
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