Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ

Completed

Conditions studied: Hemophilia A

In brief

Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.

Key facts

Study ID

NCT02962765

Run by

Octapharma

People needed

80

Starts

2015-01-01

Expected to finish

2020-08-20

Last updated by the study team

2021-10-21

Who can join

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

You may qualify if…

• Haemophilia A (FVIII:C ≤ 2%) based on medical history; at least 100 patients should have severe haemophilia A (FVIII:C < 1%)
• Male patients of any age
• Previous treatment with a FVIII concentrate for more than 150 EDs
• Availability of detailed documentation (patient diary, log book, etc.) covering either the last 50 EDs or the last 2 years per patient to confirm treatment modality (i.e., prophylaxis, on-demand, recent surgery, or immune tolerance induction)
• Inhibitor negative (< 0.6 BU) at study entry as confirmed by a recovery test with previous FVIII product and inhibitor test in a central laboratory
• Immunocompetence (CD4+ count > 200/µL), HIV-negative, or having a viral load < 200 particles/µL or < 400,000 copies/mL
• Decision to prescribe Human-cl rhFVIII before enrolment into the study
• Written informed consent by the patient or the patient's parent or legal guardian

You may not qualify if…

• Patients treated with any investigational medicinal product (IMP) except FVIII IMP within 30 days prior to the Screening Visit or patients planning to undergo treatment with any IMP other than Human-cl rhFVIII are not eligible for enrolment into the study.

Where it is running

• University of Florida — Gainesville, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Tulane University — New Orleans, Louisiana, United States
• Hemophilia Treatment Center of Nevada — Las Vegas, Nevada, United States
• Gulf States Hemophilia and Thrombophilia — Houston, Texas, United States
• Centro de Tratamiento de la Hemofilia Cordoba — Córdoba, Argentina
• CTH Centro de Tratamiento de Hematologia y Hemoterapia Córdoba S.A. — Córdoba, Argentina
• Fundación de Hemofilia de Salta — Salta, Argentina
• Centro Mayo — Santiago del Estero, Argentina
• Belarusian Research Center for Pediatric Oncology, Hematology and Immunology — Borovlyany, Belarus
• Fakultní nemocnice Brno — Brno, Czechia
• Blood Centre, University Hospital — Ostrava, Czechia
• Hospital de Especialidades Teodoro Maldonado Carbo — Guayaquil, Ecuador
• CHU Hôtel Dieu — Nantes, France
• Hopital Pontchaillou — Rennes, France
• CHRU Hôpital Nord — Saint-Priest-en-Jarez, France
• CRTH, Hopital Purpan — Toulouse, France
• Pedias Inc. Centro Hospitalario La Paz — Guatemala City, Guatemala
• L'Azienda Ospedaliero Universitaria Consorziale Policlinico, U.O. di Medicina Trasfusionale, Centro Emofilia e Trombosi — Bari, Italy
• U.O.C. Ematologia, Ospedale San Giacomo Apostolo — Castelfranco Veneto, Italy
• UOC Malattie emorragiche e della coagulazione, Azienda Ospedaliera Universitaria Careggi — Florence, Italy
• Fondazione IRCCS Ca Granda — Milan, Italy
• AOU Federico II - Dipartimento di Medicina Clinica e Chirurgica — Naples, Italy
• Azienda Sanitaria Locale Napoli 1 Centro — Naples, Italy
• Azienda Ospedaliera di Padova — Padova, Italy

Full record on ClinicalTrials.gov

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