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NCT00168103 · ClinicalTrials.gov registry record · Phase 2
Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
A Phase 2 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT00168103: Completed Phase 2 study, sponsored by CSL Behring.
NCT00168103 is a Phase 2 study that has completed, run by CSL Behring. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00168103, a Phase 2 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study was designed to provide clinically relevant data on dosing, efficacy and safety in subjects with HAE.
Primary Outcome
The start of symptom relief was determined by subject self-assessment. Time to start of symptom relief was set to 24 hours if the subject received rescue medication (blinded study medication, narcotic analgesics, antiemetics, open-label C1-INH, or fresh frozen plasma) at any time point after the start of study treatment but before start of relief.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL C1 Esterase Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
What the finished NCT00168103 record still lists
NCT00168103 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00168103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00168103 about?
NCT00168103 is a clinical study titled "Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks". HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study was designed to provid...
What is the current status of trial NCT00168103?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2005-06. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00168103?
The interventions under investigation include: Placebo (BIOLOGICAL), C1 Esterase Inhibitor (BIOLOGICAL).
Who is sponsoring clinical trial NCT00168103?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00168103's enrollment target sits among peer trials
126 556th of 2000 higher than 1,443 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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