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NCT01392547 Clinical Trial

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

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
See also
  Status Clinical Trial Phase
Completed NCT00978380 - Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 Phase 3
Completed NCT02568202 - Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) N/A
Completed NCT01949792 - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors Phase 1
Completed NCT01205724 - Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A Phase 1
Completed NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State Phase 1
Completed NCT00108797 - Trial of NovoSeven® in Haemophilia - Joint Bleeds Phase 4
Completed NCT01493778 - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A Phase 3
Completed NCT02490787 - Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects Phase 1
Completed NCT00951405 - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors Phase 2
Completed NCT01876745 - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan N/A
Completed NCT02920398 - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A Phase 1
Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A

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