A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

Status: Recruiting
Phase:
Diagnosis: Pediatric Hematology/Blood Related
NCT ID: NCT01731600 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Ellis Neufeld, MD, PhD, Brigham and Women's Hospital

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Male patients with severe congenital haemophilia A (FVIII activity level below 1%) - Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII products for patients aged 6-11 years and above 50 ED to FVIII products for patients aged 0-5 years Exclusion Criteria: - Any history of FVIII inhibitors
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