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NCT00261053 Clinical Trial

Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Genetic Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00261053
Other study ID # C1 1202-01
Secondary ID
Status Completed
Phase Phase 2
First received December 1, 2005
Last updated April 24, 2013
Start date June 2003
Est. completion date December 2005

Study information
Verified date April 2013
Source Pharming Technologies B.V.
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date December 2005
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• i.v. recombinant human C1 inhibitor

Locations
Country Name City State
Netherlands For information contact Sonja Visscher Leiden

Sponsors (1)
Lead Sponsor Collaborator
Pharming Technologies B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary outcomes: Relief of angioedema symptoms
Secondary Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics
See also
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Completed NCT00851409 - A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration Phase 2
Completed NCT00262301 - Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema Phase 3
Completed NCT01902901 - Clinical Implementation of Carrier Status Using Next Generation Sequencing N/A
Completed NCT00578435 - Allogeneic Bone Marrow Transplantation for the Treatment of Genetic Disorders of Erythropoiesis Phase 2
Recruiting NCT03911531 - Whole Exome Sequencing and Whole Genome Sequencing for Nonimmune Fetal/Neonatal Hydrops
Completed NCT01401257 - Phase II, Randomized, Placebo-controlled Trial in Patients With Charcot-marie-tooth Disease Type 1A Phase 2
Completed NCT00262288 - Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema Phase 2/Phase 3
Not yet recruiting NCT00214448 - Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples N/A