Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.


Clinical Trial Description

This is an open label trial. The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00456508
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date April 1, 2007
Completion date September 1, 2010

See also
  Status Clinical Trial Phase
Completed NCT02865720 - Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE) Phase 3
Completed NCT04861090 - A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis
Recruiting NCT05489640 - A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home
Completed NCT02584959 - Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema Phase 3
Completed NCT01826916 - EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema Phase 2
Completed NCT04057131 - FIRAZYR General Drug Use-Results Survey (Japan)
Recruiting NCT05819775 - CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema Phase 3
Recruiting NCT05397431 - A Survey of Lanadelumab in Participants With Hereditary Angioedema
Completed NCT02741596 - Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE Phase 3
Completed NCT02093923 - A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants Phase 1
Completed NCT01541423 - A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema
Completed NCT03845400 - A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
Completed NCT02586805 - Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE Phase 3
Completed NCT02052141 - Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema Phase 3
Completed NCT03888755 - A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants Phase 3
Recruiting NCT05147181 - A Study With Lanadelumab in Persons With Hereditary Angioedema (HAE) in Poland
Recruiting NCT05469789 - A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
Completed NCT05460325 - A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE) Phase 3
Completed NCT01095510 - CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 Phase 2
Recruiting NCT05578417 - A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada