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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 is a Phase 3 study that has completed, run by Pharming Technologies B.V.. The registered enrollment target is 75 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01188564
The ClinicalTrials.gov registry entry for NCT01188564 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharming Technologies B.V., which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo (Saline) is the first listed.
NCT01188564 reports 0 study locations.
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.
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