Hereditary angioedema: Validation of the end point time to onset of relief by correlation with symptom intensity.

@article{Bernstein2011HereditaryAV,
  title={Hereditary angioedema: Validation of the end point time to onset of relief by correlation with symptom intensity.},
  author={J A Bernstein and Bruce Ritchie and Robyn J. Levy and Richard L. Wasserman and Againdra K. Bewtra and David S. Hurewitz and Krystyna Obtułowicz and Avner Reshef and Dumitru Moldovan and Todor Shirov and Vesna Grivcheva-Panovska and Peter C. Kiessling and H. -O. Keinecke and Timothy John Craig},
  journal={Allergy and asthma proceedings},
  year={2011},
  volume={32 1},
  pages={36-42}
}
Time to onset of symptom relief in hereditary angioedema (HAE) is a common primary end point in clinical studies but it has never been validated by correlation with the course of HAE symptoms. This study was designed as a retrospective validation of the primary end point for a placebo-controlled phase II/III study in patients with HAE. Ninety-eight abdominal attacks were treated with 10 or 20 U/kg of a highly purified C1 esterase inhibitor (C1-INH) concentrate or placebo. The primary end point… CONTINUE READING

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Efficacy of human C1-esterase inhibitor (C1-INH) concentrate compared to pla cebo in patients with acute abdominal or facial HAE attacks

  • TJ Craig, RJ Levy, RL Wasserman
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