C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
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| ClinicalTrials.gov Identifier: NCT00289211 |
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Recruitment Status :
Completed
First Posted : February 9, 2006
Results First Posted : June 2, 2010
Last Update Posted : June 11, 2021
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Sponsor:
Shire
Information provided by (Responsible Party):
Takeda ( Shire )
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Hereditary Angioedema |
| Interventions |
Biological: C1 esterase inhibitor [human] (C1INH-nf) Drug: Placebo (saline) |
| Enrollment | 83 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | C1INH-nf | Placebo | Open-label C1INH-nf Only |
|---|---|---|---|
 Arm/Group Description |
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. | Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered. | Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only. |
| Period Title: Overall Study | |||
| Started | 36 | 35 | 12 |
| Completed | 36 | 34 | 2 |
| Not Completed | 0 | 1 | 10 |
Baseline Characteristics
| Arm/Group Title | C1INH-nf | Placebo | Open-label C1INH-nf Only | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
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. | Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered. | Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 36 | 35 | 12 | 83 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 36 participants | 35 participants | 12 participants | 83 participants | |
| 36.8 (17.68) | 37.0 (13.76) | 36.3 (19.42) | 36.8 (16.20) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 36 participants | 35 participants | 12 participants | 83 participants | |
| Female |
27 75.0%
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28 80.0%
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6 50.0%
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61 73.5%
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| Male |
9 25.0%
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7 20.0%
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6 50.0%
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22 26.5%
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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: | NCT00289211 |
| Other Study ID Numbers: |
LEVP2005-1/Part A |
| First Submitted: | February 7, 2006 |
| First Posted: | February 9, 2006 |
| Results First Submitted: | March 17, 2010 |
| Results First Posted: | June 2, 2010 |
| Last Update Posted: | June 11, 2021 |