Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 6 - 11 |
| Updated: | 12/14/2018 |
| Start Date: | March 20, 2014 |
| End Date: | May 4, 2017 |
A Phase 3, Multicenter, Randomized, Single-Blind, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Intravenous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) for the Prevention of Angioedema Attacks in Children 6 to 11 Years of Age With Hereditary Angioedema
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units
and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent
angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).
Secondary Objectives - To assess the safety and tolerability, characterize the
pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose
levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.
and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent
angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).
Secondary Objectives - To assess the safety and tolerability, characterize the
pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose
levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.
Inclusion Criteria:
- Diagnosis of Type I or Type II HAE.
- History of angioedema attacks.
Exclusion Criteria:
- History of bleeding or clotting abnormality.
- Diagnosis of acquired angioedema or known to have C1 INH antibodies.
- History of allergic reaction to C1 esterase inhibitor or other blood products.
- Receipt of any experimental agents other than those required for prevention or
treatment of angioedema attacks within 30 days prior to screening.
We found this trial at
4
sites
Colorado Springs, Colorado 80907
Principal Investigator: Daniel Soteres, MD
Phone: 719-473-8330
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Eugene, Oregon 97401
Principal Investigator: Kraig Jacobson, MD
Phone: 541-431-9437
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Frankfurt, 60590
Principal Investigator: Emel Aygoren-Pursun, MD
Phone: +496963016312
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Las Vegas, Nevada 89106
Principal Investigator: Jim Christensen, MD
Phone: 702-384-9101
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