Studies

Interventional Recruiting Phase 3

NCT06568302 on ClinicalTrials.gov

The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial

Official title: A Global Open-label Extension Study to Observe the Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial

  • Sponsor: ApcinteX Ltd
  • Collaborators: Centessa Pharmaceuticals plc
  • Enrollment: 150 (Estimated)
  • Study start: 2024-07-11 (Actual)
  • Primary completion: 2028-11-01 (Estimated)
  • Study completion: 2028-11-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Sequential
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia

Conditions

  • Hemophilia a
  • Hemophilia B
  • Hemophilia a with Inhibitor
  • Hemophilia B with Inhibitor

Intervention / Treatment

  • Drug: SerpinPC

Primary Outcome Measures

  • Treated bleeds, expressed as annualized bleeding rate (ABR) (Month 0 to Month 25 or Early termination)

Countries

Armenia, Australia, Belgium, Canada, France, Georgia, Germany, India, Italy, Moldova, Republic of, Poland, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States

Locations and Investigators

  • University of Colorado School of Medicine, Aurora, United States (Not yet recruiting)
    • Michael Wang
  • University of Iowa Healthcare, Iowa City, United States (Not yet recruiting)
    • Steven Lentz
  • Hemophilia Center of Western Pennsylvania, Pittsburgh, United States (Not yet recruiting)
    • Craig Seaman
  • Yeolyan Hematology and Oncology Center, MoH of Armenia CJSC, Yerevan, Armenia (Not yet recruiting)
    • Heghine Khachatryan
  • Royal Prince Alfred Hospital, Camperdown, Australia (Not yet recruiting)
    • Liane Khoo
  • The Alfred Hospital, Melbourne, Australia (Not yet recruiting)
  • Clin. Univ. St. Luc UCL, Bruxelles, Belgium (Not yet recruiting)
    • Cedric Hermans
  • Hamilton Health Sciences Corporation, Hamilton, Canada (Not yet recruiting)
    • Davide Matino
  • CHRU de Lille - Centre de biologie et pathologie de Lille, Centre de biologie et pathologie Pierre-Marie Degand, Lille, France (Not yet recruiting)
    • Sophie Susen
  • Hopital Necker - Enfants Malades, Paris, France (Withdrawn)
  • ARENSIA Exploratory Medicine LLC, Tbilisi, Georgia (Recruiting)
    • Levani Makhaldiani, MD
  • Universitatsklinikum Carl Gustav Carus Dresden, Dresden, Germany (Not yet recruiting)
    • Karolin Trautmann-Grill
  • Klinik fur Angiologie Hamostaseologie Haus 12 A Gerinnungssprechstunde, Berlin, Germany (Not yet recruiting)
    • Robert Klamroth
  • K J Somaiya Super Speciality Hospital & Research Centre, Mumbai, India (Not yet recruiting)
    • Shrinath Manikrao Kshirsagar
  • K J Somaiya Super Speciality Hospital and Research Centre, Chembur, India (Withdrawn)
  • Christian Medical College Hospital, Ludhiāna, India (Not yet recruiting)
    • Joseph John
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy (Not yet recruiting)
    • Flora Peyvandi
  • Presidio Ospedaliero Universitario S. Maria della Misericordia - ASUFC, Udine, Italy (Not yet recruiting)
    • Giovanni Barillari
  • Institute of Oncology, ARENSIA Exploratory Medicine, Chisinau, Moldova, Republic of (Recruiting)
    • Irina Mocanu, MD
  • Korczowski Bartosz, Gabinet Lekarski, Rzeszów, Poland (Not yet recruiting)
    • Bartosz Korczowski
  • Phoenix Pharma Pty Ltd, Port Elizabeth, South Africa (Not yet recruiting)
    • Daniel Malan
  • Hospital Universitario La Paz, Madrid, Spain (Not yet recruiting)
    • Maria Teresa Alvarez Roman
  • Hospital Clinico Universitario Virgen de la Arrixaca, Murcia, Spain (Not yet recruiting)
  • Hospital Regional Universitario de Malaga Hospital Carlos Haya - Hospital Materno-Infantil, Málaga, Spain (Not yet recruiting)
    • Francisco Lopez Jaime
  • China Medical University Hospital, Taichung, Taiwan (Not yet recruiting)
    • Ching-Tien Peng
  • Taichung Veterans General Hospital, Taichung, Taiwan (Not yet recruiting)
    • Jiaan-Der Wang
  • National Taiwan University Hospital, Taipei City, Taiwan (Not yet recruiting)
    • Sheng-Chieh Chou
  • Taipei Veterans General Hospital, Taipei, Taiwan (Not yet recruiting)
    • Chia-Jen Liu
  • Ege University Children Hospital, İzmir, Turkey (Not yet recruiting)
    • Kaan Kavakli
  • Kent Canterbury Hospital, Canterbury, United Kingdom (Not yet recruiting)
    • Gillian Evans
  • Oxford University Hospital, Oxford, United Kingdom (Not yet recruiting)
    • Susan Shapiro
  • Glasgow Royal Infirmary, Glasgow, United Kingdom (Not yet recruiting)
    • Catherine Bagot
  • University Hospital of Wales, Cardiff, United Kingdom (Not yet recruiting)
    • Samya Obaji
  • Barts and London School of Medicine and Dentistry, London, United Kingdom (Not yet recruiting)
    • Sutesh Sivapalaratnam
  • Royal Free Hospital NHS Foundation Trust, London, United Kingdom (Not yet recruiting)
    • Pratima Chowdary
  • Imperial College Healthcare NHS Trust, London, United Kingdom (Not yet recruiting)
    • Ferras Alwan
  • Royal Victoria Infirmary, Newcastle Upon Tyne, United Kingdom (Not yet recruiting)
    • Katherine Talks