Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

In brief

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

Key facts

Study ID

NCT01392547

Run by

Novo Nordisk A/S

People needed

72

Starts

2011-07-01

Expected to finish

2012-08-01

Last updated by the study team

2017-05-15

Who can join

Age: 12 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
• Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry

You may not qualify if…

• Previous participation in this trial defined as withdrawal after administration of trial product
• Patient has received an investigational medicinal product within 30 days prior to this trial
• Congenital or acquired coagulation disorders other than haemophilia A or B
• Any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records)
• Platelet count of less than 50,000 platelets/mcL (at the screening visit)
• ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges)
• Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial
• Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial
• HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than 200/mcL (defined by medical records)

Where it is running

• Novo Nordisk Clinical Trial Call Center — Tucson, Arizona, United States
• Novo Nordisk Clinical Trial Call Center — Los Angeles, California, United States
• Novo Nordisk Clinical Trial Call Center — Los Angeles, California, United States
• Novo Nordisk Clinical Trial Call Center — Orange, California, United States
• Novo Nordisk Clinical Trial Call Center — Aurora, Colorado, United States
• Novo Nordisk Clinical Trial Call Center — Tampa, Florida, United States
• Novo Nordisk Clinical Trial Call Center — Atlanta, Georgia, United States
• Novo Nordisk Clinical Trial Call Center — Augusta, Georgia, United States
• Novo Nordisk Clinical Trial Call Center — Iowa City, Iowa, United States
• Novo Nordisk Clinical Trial Call Center — Boston, Massachusetts, United States
• Novo Nordisk Clinical Trial Call Center — Detroit, Michigan, United States
• Novo Nordisk Clinical Trial Call Center — Brooklyn, New York, United States
• Novo Nordisk Clinical Trial Call Center — Portland, Oregon, United States
• Novo Nordisk Clinical Trial Call Center — Richmond, Virginia, United States
• Study site — Linz, Austria
• Study site — Campinas, São Paulo, Brazil
• Study site — Zagreb, Croatia
• Study site — Athens, Greece
• Study site — Budapest, Hungary
• Study site — Milan, Italy
• Study site — Shinjuku-ku, Tokyo, Japan
• Study site — Kuala Lumpur, Malaysia
• Study site — Warsaw, Poland
• Novo Nordisk Clinical Trial Call Center — San Juan, Puerto Rico
• Study site — Timișoara, Timiș County, Romania

Full record on ClinicalTrials.gov

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