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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: Completed Phase 2 study, sponsored by Pharming Technologies B.V..
NCT01359969 is a Phase 2 study that has completed, run by Pharming Technologies B.V.. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to beginning of relief of symptoms that showed the response to treatment based on the overall VAS score decrease of ≥ 20 mm from baseline. Separate VAS forms will be given to express the current feelings considering the severity of angioedema symptoms for five possible anatomical locations. The form will be completed by placing vertical marks on each of the 100 mm horizontal lines. The Abdominal VAS measures the patient's perceptions relating to illness, pain, bloodedness, and nausea; the o
Interventions
- DRUG rhC1INH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2012-01-17 |
| Est. Completion | 2017-07-17 |
| Phase | Phase 2 |
What the finished NCT01359969 record still lists
NCT01359969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which rhC1INH is the first listed.
NCT01359969 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01359969's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 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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