Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Sponsor
Pharming Technologies B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT00261053
Collaborator
(none)
14
1
1
30
0.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
14 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Jun 1, 2003
Actual Primary Completion Date
:
Sep 1, 2005
Actual Study Completion Date
:
Dec 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 1 Open-label i.v. administration of 100 U/kg rhC1INH |
Drug: i.v. recombinant human C1 inhibitor
|
Outcome Measures
Primary Outcome Measures
- Primary outcomes: Relief of angioedema symptoms []
Secondary Outcome Measures
- Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For information contact Sonja Visscher | Leiden | Netherlands | 2333 CN |
Sponsors and Collaborators
- Pharming Technologies B.V.
Investigators
- Study Chair: Jan Nuijens, MD, PhD, Pharming Technologies B.V.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00261053
Other Study ID Numbers:
- C1 1202-01
First Posted:
Dec 2, 2005
Last Update Posted:
Apr 25, 2013
Last Verified:
Apr 1, 2013
Additional relevant MeSH terms: