Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients

Completed · Phase 3

Conditions studied: Severe Hemophilia A

In brief

Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

Key facts

Study ID

NCT01712438

Run by

Octapharma

People needed

110

Starts

2013-02-01

Expected to finish

2019-12-20

Last updated by the study team

2021-01-19

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patients
• Severe Hemophilia A (FVIII:C <1%)
• No previous treatment with FVIII concentrates or other blood products containing FVIII

You may not qualify if…

• Diagnosis with a coagulation disorder other than Hemophilia A
• Severe liver or kidney disease
• Concomitant treatment with any systemic immunosuppressive drug

Where it is running

• UC Davis — Sacramento, California, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Harvard Children's Hospital Boston — Boston, Massachusetts, United States
• Republican Scientific Practical Center for Pediatric Oncology and Hematology — Minsk, Belarus
• University of Alberta — Edmonton, Alberta, Canada
• BC Children's Hospital — Vancouver, British Columbia, Canada
• Mc Master Children's Hospital — Hamilton, Ontario, Canada
• Hospital for Sick Children — Toronto, Ontario, Canada
• Hopital Ste-Justine — Montreal, Quebec, Canada
• L'hôpital Côte de Nacre - CHU de Caen — Caen, France
• Centre de traitement de l'hemophilie, Hôpital Bicêtre — Le Kremlin-Bicêtre, France
• Hopital de la Timone — Marseille, France
• Hôtel-Dieu de Nantes, Centre Regional de Traitement de l'hemophilie — Nantes, France
• Hôpital Necker — Paris, France
• CHU de Rennes - Hôpital Pontchaillou — Rennes, France
• Hopital Trousseau - CHU Tours — Tours, France
• Institute of Haematology and Transfusiology — Tbilisi, Georgia
• Institut für Experimentelle Hämatologie und Transfusionsmedizin (IHT) — Bonn, Germany
• University Hospital Frankfurt/M — Frankfurt, Germany
• Universitätsmedizin der Johannes-Gutenberg-Universität Mainz — Mainz, Germany
• Kasturba Medical College, Dr. TMA Pai Hospital — Manipal, Karnataka, India
• Sahyadri Speciality Hospital, Haematology & BMT Unit — Pune, India
• Christian Medical College & Hospital, Dept of Haematology — Vellore, India
• Univ. Di Perugia — Perugia, Italy
• Centro di Referimento per le Malattie Emorragiche e Trombotiche — Torino, Italy

Full record on ClinicalTrials.gov

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