Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors (adept™2)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Haemophilia B With Inhibitors; Haemophilia A With Inhibitors; Congenital Bleeding Disorder

Treatments: Drug: vatreptacog alfa (activated); Drug: eptacog alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392547

JapicCTI-111595 (Registry Identifier)

NN1731-3562

U1111-1118-2228 (Other Identifier)

2010-023803-92 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.

Enrollment: 72 patients

Sex: Male

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 2 patient groups

rFVIIa

Experimental group

Treatment:

Drug: eptacog alfa (activated)

vatreptocog alfa

Experimental group

Treatment:

Drug: vatreptacog alfa (activated)