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NCT01359969 · ClinicalTrials.gov registry record · Phase 2
Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients
A Phase 2 study, sponsored by Pharming Technologies B.V..
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT01359969 is a Phase 2 study that has completed, run by Pharming Technologies B.V.. The registered enrollment target is 57 participants.
The verdict
NCT01359969, a Phase 2 study, has completed, sponsored by Pharming Technologies B.V..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including 13 years of age.
Interventions
- DRUG rhC1INH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2012-01-17 |
| Est. Completion | 2017-07-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01359969
The ClinicalTrials.gov registry entry for NCT01359969 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 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 1 intervention - of which rhC1INH is the first listed.
NCT01359969 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01359969 about?
NCT01359969 is a clinical study titled "Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients". This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including 13 years of age.
What is the current status of trial NCT01359969?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2012-01-17. Estimated completion is 2017-07-17.
What interventions are being tested in trial NCT01359969?
The interventions under investigation include: rhC1INH (DRUG).
Who is sponsoring clinical trial NCT01359969?
This trial is sponsored by Pharming Technologies B.V., which has 11 total clinical trials registered on ClinicalTrials.gov.
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