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Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients

NCT01359969 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-03-29

Study results available
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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.

Conditions

Interventions

DRUG

rhC1INH

Patients up to 84 kg will receive one i.v. injection of Ruconest at a dose of 50 U/kg. The reconstituted solution should be administered as a slow i.v. injection over approximately 5 minutes. Patients of 84 kg body weight or greater will receive one i.v. injection of Ruconest at the dose of 4200 U (2 vials).

Sponsors & Collaborators

  • Pharming Technologies B.V.

    lead INDUSTRY

Principal Investigators

  • Anurag Relan, MD · VP Clinical Research & Medical Affairs at Pharming

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-17
Primary Completion
2017-07-17
Completion
2017-07-17
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Hungary
  • Israel
  • Italy
  • North Macedonia
  • Poland
  • Romania
  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01359969 on ClinicalTrials.gov