Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks (CHANGE 2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00438815 |
Recruitment Status :
Completed
First Posted : February 22, 2007
Results First Posted : June 9, 2010
Last Update Posted : June 8, 2021
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Sponsor:
Shire
Information provided by (Responsible Party):
Takeda ( Shire )
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Hereditary Angioedema |
Intervention |
Biological: C1 esterase inhibitor [human] (C1INH-nf) |
Enrollment | 113 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Open-label C1INH-nf |
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1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered. |
Period Title: Overall Study | |
Started | 113 |
Completed | 43 |
Not Completed | 70 |
Reason Not Completed | |
Transferred to LEVP2006-4 (NCT00462709) | 30 |
3-month follow-up no longer required | 12 |
Noncompliance with protocol requirements | 9 |
Transitioned to commercial C1INH-nf | 6 |
Lost to Follow-up | 6 |
Withdrawal by Subject | 6 |
Death | 1 |
Baseline Characteristics
Arm/Group Title | Open-label C1INH-nf | |
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1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered. | |
Overall Number of Baseline Participants | 113 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 113 participants | |
34.5 (17.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 113 participants | |
Female |
75 66.4%
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Male |
38 33.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Clinical Study Agreement. Most restrictive provision - PI will not publish results until after first of: multicenter publication is published or 24 months from study end. Thereafter, PI may publish his results. PI must provide copy of proposed publication to sponsor for pre-review. If sponsor requests, PI must delete sponsor confidential information before publication and/or delay publication for 90 days so sponsor can file for patents or take other action to protect its patent rights.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Shire |
Phone: | +1 866 842 5335 |
EMail: | ClinicalTransparency@shire.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Takeda ( Shire ) |
ClinicalTrials.gov Identifier: | NCT00438815 |
Other Study ID Numbers: |
LEVP2006-1 |
First Submitted: | February 21, 2007 |
First Posted: | February 22, 2007 |
Results First Submitted: | March 31, 2010 |
Results First Posted: | June 9, 2010 |
Last Update Posted: | June 8, 2021 |