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

Congenital Bleeding Disorder Clinical Trial

— adept™2  

Official title:

Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients With Congenital Haemophilia and Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392547
• Other study ID #: NN1731-3562
• Secondary ID: 2010-023803-92U1
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2011
• Last updated: December 12, 2014
• Start date: July 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBrazil: National Health Surveillance AgencyCroatia: Ministry of Health and Social CareGreece: Ministry of HealthHungary: Ministry of Health, Social and Family AffairsItaly: The Italian Medicines AgencyJapan: Ministry of Health, Labor and WelfareMalaysia: Ministry of HealthPoland: Ministry of HealthRomania: National Medicines AgencyRussia: Federal Service for Control of Health Care and Social DevelopmentSerbia: Agency for Drugs and Medicinal DevicesSouth Africa: Medicines Control CouncilTaiwan: Department of HealthThailand: Thai FDATurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A With Inhibitors
• Haemophilia B With Inhibitors
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• vatreptacog alfa (activated)
1-3 doses per bleeding episode
• eptacog alfa (activated)
1-3 doses per bleeding episode

Locations

Country	Name	City	State
Puerto Rico	Novo Nordisk Clinical Trial Call Center	San Juan
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	Aurora	Colorado
United States	Novo Nordisk Clinical Trial Call Center	Boston	Massachusetts
United States	Novo Nordisk Clinical Trial Call Center	Brooklyn	New York
United States	Novo Nordisk Clinical Trial Call Center	Detroit	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Iowa City	Iowa
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	Portland	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Richmond	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Tampa	Florida
United States	Novo Nordisk Clinical Trial Call Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Croatia,  Greece,  Hungary,  Italy,  Japan,  Malaysia,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  South Africa,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given		Within 12 hours of first trial product administration	No
Secondary	Effective and Sustained Bleeding Control		Up to 48 hours after first trial product administration	No
Secondary	Number of Doses of Trial Product Given for Each Acute Bleed		Up to 6 hours after first trial product administration	No
Secondary	Number of Adverse Events	Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.	No
Secondary	Immunogenicity (Inhibitor Development)	Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or FVII. Radioimmunoassay using [125I]-labelled vatreptacog alfa or rFVIIa was used to screen plasma samples for development of anti-drug antibodies	Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product.	No

External Links

•   Clinical Trials at Novo Nordisk