An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated rhC1INH Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency (HAE)

Trial Profile

An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated rhC1INH Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency (HAE)

Completed
Phase of Trial: Phase II

Latest Information Update: 16 Jan 2018

At a glance

  • Drugs Conestat alfa (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms OPERA
  • Sponsors Pharming Group NV
  • Most Recent Events

    • 16 Jan 2018 According to a Pharming Group media release, based on the data from this and another trial (CT profile 700249916), the U.S. Food and Drug Administration (FDA) has accepted for review supplemental Biologics License Application (sBLA) for RUCONEST [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE). The FDA has set an action date of September 21, 2018.
    • 27 Nov 2017 According to a Pharming NV media release, based on the data from this and another trial (CT profile 700249916), the company has submitted a supplemental Biologics License Application (BLA) to the US FDA for RUCONEST (Recombinant Human C1 Esterase Inhibitor/conestat alfa) for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema.
    • 11 Sep 2017 According to a Pharming Group media release, base on the data from this and another study CTP700249916, company will submit a BLA efficacy supplement (sBLA) to include routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE) as an expanded indication for RUCONEST (Conestat-alfa) in Q4 2017.
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