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NCT01188564 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
A Phase 3 study, sponsored by Pharming Technologies B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
NCT01188564: Completed Phase 3 study, sponsored by Pharming Technologies B.V..
NCT01188564 is a Phase 3 study that has completed, run by Pharming Technologies B.V.. The registered enrollment target is 75 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01188564, a Phase 3 study, has completed, sponsored by Pharming Technologies B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
Study Summary
This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients.
Primary Outcome
Time to beginning of relief is the time lapsed from the beginning of the infusion of study medication to the beginning of a beneficial effect based on patient's responses to the Treatmetn Effect Questionnaire (TEQ) for the primary attack location. The beginning of relief is defined as the first timepoint at which * The patient reports any of the following answers for TEQ question 1: "A little better", "Better" or "Much better"; and; * The patient reports the following answer for TEQ question 2:
Interventions
- DRUG Placebo (Saline)
- DRUG rhC1INH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT01188564 record still lists
NCT01188564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo (Saline) is the first listed.
NCT01188564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01188564 about?
NCT01188564 is a clinical study titled "Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks". This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients.
What is the current status of trial NCT01188564?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2011-01. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01188564?
The interventions under investigation include: Placebo (Saline) (DRUG), rhC1INH (DRUG).
Who is sponsoring clinical trial NCT01188564?
This trial is sponsored by Pharming Technologies B.V., which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01188564's enrollment target sits among peer trials
75 1773rd of 2000 higher than 221 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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