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

Purpose

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.

Condition	Intervention	Phase
Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors	Drug: NNC 0078-0000-0007 Drug: eptacog alfa (activated)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients With Congenital Haemophilia and Inhibitors

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bleeding Disorders Hemophilia

Drug Information available for: Eptacog alfa

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Effective bleeding control defined as no additional haemostatic medication (other than trial product) given [ Time Frame: Within 12 hours of first trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effective and sustained bleeding control [ Time Frame: Up to 48 hours after first trial product administration ] [ Designated as safety issue: No ]
Number of doses of trial product given for each acute bleed [ Time Frame: Up to 6 hours after first trial product administration ] [ Designated as safety issue: No ]
Number of adverse events [ Time Frame: After approximately 21 months (at end of trial) ] [ Designated as safety issue: No ]
Immunogenicity [ Time Frame: After approximately 21 months (at end of trial) ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	July 2011
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment of acute bleeds (1)	Drug: NNC 0078-0000-0007 1-3 doses per bleeding episode
Active Comparator: Treatment of acute bleeds (2)	Drug: eptacog alfa (activated) 1-3 doses per bleeding episode

Detailed Description:

Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 every 3 months

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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 start

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392547

Show 34 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Tina Lund

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01392547 History of Changes
Other Study ID Numbers:	NN1731-3562, 2010-023803-92, U1111-1118-2228, JapicCTI-111595
Study First Received:	July 8, 2011
Last Updated:	October 17, 2012
Health Authority:	Austria: The Austrian Agency for Health and Food Safety (AGES) Brazil: National Health Surveillance Agency Croatia: Ministry of Health and Social Care Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Greece: Ministry of Health Hungary: Ministry of Health, Social and Family Affairs India: Ministry of Health Italy: The Italian Medicines Agency Japan: Ministry of Health, Labor and Welfare Malaysia: Ministry of Health Poland: Ministry of Health Romania: National Medicines Agency Russia: Federal Service for Control of Health Care and Social Development Serbia: Agency for Drugs and Medicinal Devices South Africa: Medicines Control Council Spain: Spanish Agency of Medicines and Health Care Products Switzerland: Swissmedic Taiwan: Department of Health Thailand: Thai FDA Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA) United States: Food and Drug Administration

Additional relevant MeSH terms:

Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia B
Hemophilia A
Hemorrhage
Hematologic Diseases

Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013

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