Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

Completed · Phase 3

Conditions studied: Severe Hemophilia A

In brief

The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.

Key facts

Study ID

NCT01992549

Run by

Octapharma

People needed

48

Starts

2014-04-01

Expected to finish

2018-12-27

Last updated by the study team

2021-01-19

Who can join

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

You may qualify if…

• Patients who completed GENA-05 in accordance with the study protocol

You may not qualify if…

• Severe liver or kidney disease
• Concomitant treatment with any systemic immunosuppressive drug;
• Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of GENA-05 and start of GENA-15 (except emergency cases).

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• University of Alberta — Edmonton, Alberta, Canada
• BC Children's Hospital — Vancouver, British Columbia, Canada
• McMaster Children's Hospital — Hamilton, Ontario, Canada
• Hospital for Sick Children — Toronto, Canada
• Hopital de la Timone — Marseille, France
• Hôpital Kremlin Bicètre — Paris, France
• Institute of Hematology and Transfusiology — Tbilisi, Georgia
• Sahyadri Speciality Hospital — Pune, India
• Christian Medical College — Vellore, India
• IMSP Mother and Child Institute — Chisinau, Moldova
• University Medical School — Warsaw, Poland
• The National Children Specialized Hospital "OHMATDET" — Kiev, Ukraine
• Danylo Halytsky Lviv National Medical University — Lviv, Ukraine
• Great Ormond Street Hospital for Children — London, United Kingdom

Full record on ClinicalTrials.gov

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