| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-7182 | Other Identifier | WHO | |
| 2009-016383-36 | EudraCT Number |
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This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFVIII | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| turoctocog alfa | Drug | Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 138 days per subject. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85016-7710 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23651313 | Result | Kulkarni R, Karim FA, Glamocanin S, Janic D, Vdovin V, Ozelo M, Rageliene L, Carboni E, Laguna P, Dobaczewski G, Seremetis S, Lindblom A, Santagostino E. Results from a large multinational clinical trial (guardian3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013 Sep;19(5):698-705. doi: 10.1111/hae.12165. Epub 2013 May 8. | |
| 25273984 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Of a total of 39 initiated trial sites, 26 sites enrolled and dosed at least one patient. The country distribution was as follows: Brazil (3), Italy (1), Lithuania (1), Macedonia (1), Malaysia (1), Poland (2), Russia (2), Serbia (1), Taiwan (1), Turkey (3) and the United States of America (10).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects Treated With Turoctocog Alfa | The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| turoctocog alfa | Drug | Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen. |
|
| The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject |
| Orange |
| California |
| 92868 |
| United States |
| Novo Nordisk Investigational Site | Torrance | California | 90502-2004 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33607 | United States |
| Novo Nordisk Investigational Site | Augusta | Georgia | 30912 | United States |
| Novo Nordisk Investigational Site | Iowa City | Iowa | 52242 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02115 | United States |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48201 | United States |
| Novo Nordisk Investigational Site | East Lansing | Michigan | 48823 | United States |
| Novo Nordisk Investigational Site | Kansas City | Missouri | 64108-4619 | United States |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68198-2168 | United States |
| Novo Nordisk Investigational Site | Brooklyn | New York | 11201-5425 | United States |
| Novo Nordisk Investigational Site | Valhalla | New York | 10595 | United States |
| Novo Nordisk Investigational Site | Dayton | Ohio | 45404 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97239-3098 | United States |
| Novo Nordisk Investigational Site | Charleston | South Carolina | 29425 | United States |
| Novo Nordisk Investigational Site | Fort Worth | Texas | 76104 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | United States |
| Novo Nordisk Investigational Site | Curitiba | Paraná | 80250-060 | Brazil |
| Novo Nordisk Investigational Site | Rio de Janeiro | Rio de Janeiro | 20211-030 | Brazil |
| Novo Nordisk Investigational Site | Campinas | São Paulo | 13081970 | Brazil |
| Novo Nordisk Investigational Site | São Paulo | São Paulo | 05403-000 | Brazil |
| Novo Nordisk Investigational Site | Milan | 20124 | Italy |
| Novo Nordisk Investigational Site | Shizuoka-shi, Shizuoka | 4208660 | Japan |
| Novo Nordisk Investigational Site | Vilnius | LT-08406 | Lithuania |
| Novo Nordisk Investigational Site | Kuala Lumpur | 50400 | Malaysia |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Warsaw | 00-576 | Poland |
| Novo Nordisk Investigational Site | Wroclaw | 50-345 | Poland |
| Novo Nordisk Investigational Site | San Juan | 00935 | Puerto Rico |
| Novo Nordisk Investigational Site | Moscow | 105077 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 191119 | Russia |
| Novo Nordisk Investigational Site | Belgrade | 11000 | Serbia |
| Novo Nordisk Investigational Site | Taipei | 40447 | Taiwan |
| Novo Nordisk Investigational Site | Adana | 01130 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Antalya | 01010 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Bornova-IZMIR | 35100 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | İzmit | 41380 | Turkey (Türkiye) |
| Result |
| Santagostino E, Lentz SR, Misgav M, Brand B, Chowdary P, Savic A, Kilinc Y, Amit Y, Amendola A, Solimeno LP, Saugstrup T, Matytsina I. Safety and efficacy of turoctocog alfa (NovoEight(R)) during surgery in patients with haemophilia A: results from the multinational guardian clinical trials. Haemophilia. 2015 Jan;21(1):34-40. doi: 10.1111/hae.12518. Epub 2014 Oct 2. |
| 26679394 | Result | Ozelo MC. Updates from guardian: a comprehensive registration programme. Eur J Haematol. 2015 Dec;95 Suppl 81:22-9. doi: 10.1111/ejh.12648. |
| Exposed |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Treated With Turoctocog Alfa | The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 safety analysis set includes all 63 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 59 subjects had 50 exposure days (EDs). | Posted | Number | N with Inhibitors / N with ≥50 EDs | The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject. |
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| ||||||||||||||||||||||||||
| 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 AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. | Safety analysis set includes all subjects who received at least one dose of the investigational product. | Posted | Number | events | The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject |
|
|
The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.
Safety analysis set includes all subjects who received at least one dose of the investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects Treated With Turoctocog Alfa | The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa. | 3 | 63 | 14 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device related infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C577506 | recombinant factor VIII N8 |
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| Italy |
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| Lithuania |
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| Macedonia, The Former Yugoslav Republic of |
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| Malaysia |
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| Poland |
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| Russia |
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| Taiwan |
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| Turkey |
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| United States |
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| Participants |
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