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Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A (guardian™4)

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

turoctocog alfa

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

0 Years - 6 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Age below 6 years
Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)
Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or below 1%)
No prior use of purified clotting factor products (previous exposure, equal to or less than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted) including commercially available NovoEight® /Novoeight®

Exclusion Criteria:

Known or suspected allergy to hamster protein or intolerance to trial product(s) or related products
Previous participation in this trial defined as withdrawal after administration of trial product
Congenital or acquired coagulation disorders other than haemophilia A
Any history of Factor VIII inhibitor
Ongoing treatment or planned treatment during the trial with immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

turoctocog alfa

Arm Description

Outcomes

Primary Outcome Measures

Incidence Rate of Factor VIII Inhibitors (Above or Equal to 0.6 BU (Bethesda Units)/mL) for the Main Phase of the Trial

The incidence rate (percentage of participants with inhibitors) of inhibitors defined as inhibitor titres ≥0.6 BU for main phase of the trial.

Secondary Outcome Measures

Haemostatic Effect of Turoctocog Alfa on Treatment of Bleeds Assessed on a Predefined Four Point Scale: Excellent, Good, Moderate and None

The haemostatic effect of turoctocog alfa was summarised by frequency tables containing count of all bleeds and assessed on a predefined four point scale: Excellent, Good, Moderate and None. The analysis was based on the total number of bleeds and their response to treatment. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Annualised Bleeding Rate (ABR)

Annualised bleeding rate defined as number of bleeds in total per patient per year following treatment were estimated by a Poisson model allowing for over-dispersion. The Poisson estimate is presented with a 95% confidence interval (CI). The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Number of Turoctocog Alfa (N8) Injections Required Per Bleed

The number of injections of turoctocog alfa (N8) required per bleed was calculated as the number of injections of turoctocog alfa used in the time period from start of the bleed to stop of the bleed. The mean number of turoctocog alfa injections required to stop the bleed is presented. The analysis was based on the total number of bleeds. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Total Consumption of Turoctocog Alfa (N8) Per Patient (Prevention, Treatment of Bleeds and During Surgery) Per Month

Mean total consumption of turoctocog alfa (N8) used for treatment (includes all injections given: prevention, treatment of bleeds and during surgery) per patient per month. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Total Consumption of Turoctocog Alfa (N8) Per Patient (Prevention, Treatment of Bleeds and During Surgery) Per Year

Mean total consumption of turoctocog alfa (N8) used for treatment (includes all injections given: prevention, treatment of bleeds and during surgery) per patient per year. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Consumption of Turoctocog Alfa (N8) (IU/kg/Bleed) Per Bleed

Mean consumption of turoctocog alfa (N8) used for treatment of bleed from start to stop of bleed. The analysis was based on number of bleeds. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Consumption of Turoctocog Alfa (N8) (IU/kg/Months) for Bleed Prevention

Mean consumption of turoctocog alfa (N8) used for preventive treatment per month per patient. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) Reported During the Trial Period

Number of adverse events and serious adverse events per patient years of exposure. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial (exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Incidence Rate of Clinically Relevant Inhibitors Defined as an Inhibitor Titre (≥ 0.6 BU/mL) Combined With a Decreased Recovery (<66% of Expected Level)

The incidence rates (number of patients with new inhibitor in the period/number of participants at risk, expressed in percentage) of clinically relevant inhibitors were defined as an inhibitor titre (≥ 0.6 BU) combined with a decreased recovery (<66% of expected level). Incidence rate of clinically relevant inhibitors according to the type of assay used is presented. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation) and the combined main and extension phase (from Visit 2 to end of trial).

Incidence Rate of High-titre Inhibitors Defined as Inhibitor Titre ≥ 5 BU (Bethesda Units)/mL)

Incidence rate (number of patients with new inhibitor in the period/number of participants at risk, expressed in percentage) of high-titre inhibitors defined as inhibitor titre ≥ 5 BU (Bethesda Units)/mL). The inhibitors were evaluated for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation) and the combined main and extension phase (from Visit 2 to end of trial).

Change in Total Scores for Parent Reported Treatment Satisfaction

The caregivers/parent reported treatment satisfaction is assessed by the parents using the haemophilia satisfaction questionnaire (HEMO-SAT). The questionnaire contained questions related to treatment that covered 6 domains (ease and convenience, efficacy, burden, specialist, centre and general satisfaction). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. The scores of the domains at visit 3 (10th-15th ED), visit 5 (50th-55th ED) and end of trial (EoT) are presented.

Health Resource Utilization and Caregiver Burden Associated With Bleeds (Per Month Per Patient)

Resource utilisation and caregiver burden are analysed in terms of average number of days absent from work and use of mobility aids (e.g. wheelchair or crutches) as a consequence of bleeds. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Health Resource Utilization and Caregiver Burden Associated With Bleeds (Per Year Per Patient)

Resource utilisation and caregiver burden are analysed in terms of average number of days of absence from work and use of mobility aids (e.g. wheelchair or crutches) as a consequence of bleeds. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.

Full Information

NCT ID

NCT01493778

First Posted

December 15, 2011

Last Updated

November 26, 2020

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01493778

Brief Title

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

Acronym

guardian™4

Official Title

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Paediatric Previously Untreated Patients With Haemophilia A

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

September 17, 2012 (Actual)

Primary Completion Date

August 16, 2017 (Actual)

Study Completion Date

December 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untreated children with haemophilia A.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Bleeding Disorder, Haemophilia A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

turoctocog alfa

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

turoctocog alfa

Intervention Description

Patients will be scheduled to receive treatment with turoctocog alfa for at least 100 exposure days. In most cases, treatment will be given at home with intravenous (i.v., into the vein) self-injection by the parent/caregiver/support person.

Primary Outcome Measure Information:

Title

Incidence Rate of Factor VIII Inhibitors (Above or Equal to 0.6 BU (Bethesda Units)/mL) for the Main Phase of the Trial

Description

The incidence rate (percentage of participants with inhibitors) of inhibitors defined as inhibitor titres ≥0.6 BU for main phase of the trial.

Time Frame

From Visit 2 (21 days after screening) to Visit 5 (50-55 exposure day)

Secondary Outcome Measure Information:

Title

Haemostatic Effect of Turoctocog Alfa on Treatment of Bleeds Assessed on a Predefined Four Point Scale: Excellent, Good, Moderate and None

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Annualised Bleeding Rate (ABR)

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Number of Turoctocog Alfa (N8) Injections Required Per Bleed

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Total Consumption of Turoctocog Alfa (N8) Per Patient (Prevention, Treatment of Bleeds and During Surgery) Per Month

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Total Consumption of Turoctocog Alfa (N8) Per Patient (Prevention, Treatment of Bleeds and During Surgery) Per Year

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Consumption of Turoctocog Alfa (N8) (IU/kg/Bleed) Per Bleed

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Consumption of Turoctocog Alfa (N8) (IU/kg/Months) for Bleed Prevention

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) Reported During the Trial Period

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Incidence Rate of Clinically Relevant Inhibitors Defined as an Inhibitor Titre (≥ 0.6 BU/mL) Combined With a Decreased Recovery (<66% of Expected Level)

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Incidence Rate of High-titre Inhibitors Defined as Inhibitor Titre ≥ 5 BU (Bethesda Units)/mL)

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Change in Total Scores for Parent Reported Treatment Satisfaction

Description

Time Frame

Visit 3 (10th-15th ED); Visit 5 (50th-55th ED); End of trial (within 8 weeks of their last scheduled visit in the extension phase)

Title

Health Resource Utilization and Caregiver Burden Associated With Bleeds (Per Month Per Patient)

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

Title

Health Resource Utilization and Caregiver Burden Associated With Bleeds (Per Year Per Patient)

Description

Time Frame

From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age below 6 years Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient) Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or below 1%) No prior use of purified clotting factor products (previous exposure, equal to or less than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted) including commercially available NovoEight® /Novoeight® Exclusion Criteria: Known or suspected allergy to hamster protein or intolerance to trial product(s) or related products Previous participation in this trial defined as withdrawal after administration of trial product Congenital or acquired coagulation disorders other than haemophilia A Any history of Factor VIII inhibitor Ongoing treatment or planned treatment during the trial with immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016-7710

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010-2978

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32827

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31404

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201-5425

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11220

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45404

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84113

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Algiers

ZIP/Postal Code

16000

Country

Algeria

Facility Name

Novo Nordisk Investigational Site

City

Annaba

ZIP/Postal Code

23000

Country

Algeria

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Klagenfurt

ZIP/Postal Code

A 9026

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Salzburg

ZIP/Postal Code

A 5020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

St. Poelten

ZIP/Postal Code

A 3100

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

A 1090

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80250-060

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13081-970

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100045

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Chonqqing

State/Province

Chongqing

ZIP/Postal Code

400014

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Tianjing

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Novo Nordisk Investigational Site

City

København Ø

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-11527

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR 54642

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Shatin, New Territories

Country

Hong Kong

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1089

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hyogo

ZIP/Postal Code

654-0047

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Shizuoka

ZIP/Postal Code

420-8660

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

157-8535

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Vilnius

ZIP/Postal Code

08406

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-094

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

San Juan

ZIP/Postal Code

00935

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Krasnodar

ZIP/Postal Code

350007

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191065

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11070

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

El Palmar

ZIP/Postal Code

30120

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Adana

ZIP/Postal Code

01130

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Antalya

ZIP/Postal Code

01010

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Bornova-IZMIR

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Izmit

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Samsun

ZIP/Postal Code

55319

Country

Turkey

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

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Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A (guardian™4)

Congenital Bleeding Disorder, Haemophilia A

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial