Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

Congenital Bleeding Disorder Clinical Trial

— guardian™1  

Official title:

A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840086
• Other study ID #: NN7008-3543
• Secondary ID: 2008-003960-2010
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2009
• Last updated: January 7, 2015
• Start date: April 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyCroatia: Ministry of Health and Social CareGermany: Paul-Ehrlich-InstitutIsrael: Ministry of HealthItaly: The Italian Medicines AgencyJapan: Ministry of Health, Labor and WelfareMalaysia: Ministry of HealthRussia: Federal Service for Control of Health Care and Social DevelopmentSerbia: Medicines and Medical Devices Agency of SerbiaSpain: Spanish Agency of Medicines and Health Care ProductsSwitzerland: SwissmedicTaiwan: Department of Health, Executive Yuan, R.O.C.Turkey: Ministry of Health Drug and Pharmaceutical DepartmentUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg

• Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)

• No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A

• No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)

Exclusion Criteria:

• Congenital or acquired coagulation disorders other than haemophilia A

• Creatinine levels 50% above normal level (as defined by central laboratory range)

• Known or suspected allergy to trial product (N8) or related products

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Hemophilia A
• Hemostatic Disorders

Intervention

Drug:
• turoctocog alfa
Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Atlanta	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Cincinnati	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Dayton	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Iowa City	Iowa
United States	Novo Nordisk Clinical Trial Call Center	Nashville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Portland	Oregon
United States	Novo Nordisk Clinical Trial Call Center	Providence	Rhode Island
United States	Novo Nordisk Clinical Trial Call Center	Spokane	Washington
United States	Novo Nordisk Clinical Trial Call Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Brazil,  Croatia,  Germany,  Israel,  Italy,  Japan,  Malaysia,  Russian Federation,  Serbia,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))	The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.	The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject.	No
Secondary	Frequency of Adverse Events (AEs)	Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.	The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject	No

External Links

•   Clinical Trials at Novo Nordisk