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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)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Mar 2019

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At a glance

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

    • 29 Mar 2019 According to a Pharming Group NV media release, the additional data requested by the FDA for the review of Ruconest BLA will be gathered as part of the new acute and prophylaxis studies of ruconest in other forms of delivery (intramuscular, subcutaneous and intradermal routes of administration) designed to increase convenience for patients.
    • 19 Sep 2018 According to a Pharming Group NV media release, the U.S. FDA has issued a Complete response letter to the company regarding the sBLA for RUCONEST to expand the current indication to include prophylaxis in patients with hereditary angioedema (HAE). Based on their review, the FDA has requested an additional clinical trial to further evaluate the effectiveness of RUCONEST in HAE prophylaxis. The company is working with the FDA to generate additional clinical data required for approval.
    • 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.
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