Back to resultsRecombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Primary Purpose
Genetic Disorders
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
i.v. recombinant human C1 inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Genetic Disorders
Eligibility Criteria
Main inclusion Criteria: Clinical and laboratory diagnosis of HAE Plasma level of functional C1INH of less than 50% of normal Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE. Main exclusion Criteria: Acquired angioedema Pregnancy or breastfeeding Participation in another clinical study within prior 3 months
Sites / Locations
- For information contact Sonja Visscher
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Open-label i.v. administration of 100 U/kg rhC1INH
Outcomes
Primary Outcome Measures
Primary outcomes: Relief of angioedema symptoms
Secondary Outcome Measures
Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics
Full Information
NCT ID
NCT00261053
First Posted
December 1, 2005
Last Updated
April 24, 2013
Sponsor
Pharming Technologies B.V.
1. Study Identification
Unique Protocol Identification Number
NCT00261053
Brief Title
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Official Title
A Phase II Exploratory, Open-label Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pharming Technologies B.V.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Open-label i.v. administration of 100 U/kg rhC1INH
Intervention Type
Drug
Intervention Name(s)
i.v. recombinant human C1 inhibitor
Primary Outcome Measure Information:
Title
Primary outcomes: Relief of angioedema symptoms
Secondary Outcome Measure Information:
Title
Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion Criteria:
Clinical and laboratory diagnosis of HAE
Plasma level of functional C1INH of less than 50% of normal
Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE.
Main exclusion Criteria:
Acquired angioedema
Pregnancy or breastfeeding
Participation in another clinical study within prior 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Nuijens, MD, PhD
Organizational Affiliation
Pharming Technologies B.V.
Official's Role
Study Chair
Facility Information:
Facility Name
For information contact Sonja Visscher
City
Leiden
ZIP/Postal Code
2333 CN
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
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