Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks (CHANGE 3)
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|ClinicalTrials.gov Identifier: NCT00462709|
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : May 3, 2010
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Angioedema||Biological: C1 esterase inhibitor [human] (C1INH-nf)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks|
|Actual Study Start Date :||June 27, 2006|
|Actual Primary Completion Date :||March 31, 2009|
|Actual Study Completion Date :||March 31, 2009|
Experimental: Open-label C1INH-nf
1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days.
Biological: C1 esterase inhibitor [human] (C1INH-nf)
- Frequency of All HAE Attacks [ Time Frame: Duration of the study ]A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.
- Antigenic C1 Inhibitor (C1INH) Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.
- Functional C1INH Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]Change from pre-infusion to 1 hour post-infusion in functional C1INH serum levels. Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH).
- Complement C4 Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462709
|Study Director:||Study Director||Takeda|