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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.

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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

FieldValue
Enrollment Target 57 participants
Start Date 2012-01-17
Est. Completion 2017-07-17
Phase Phase 2

Sponsor

Pharming Technologies B.V.

11 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.