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NCT01493778

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

Last Updated: 2020-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-17

Study Completion Date

2018-12-05

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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turoctocog alfa

Group Type EXPERIMENTAL

turoctocog alfa

Intervention Type DRUG

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.

Interventions

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turoctocog alfa

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

0 Years

Maximum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Phoenix, Arizona, United States

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Long Beach, California, United States

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Sacramento, California, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Macon, Georgia, United States

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Savannah, Georgia, United States

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Oak Lawn, Illinois, United States

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Detroit, Michigan, United States

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Las Vegas, Nevada, United States

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New Brunswick, New Jersey, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Charleston, South Carolina, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Algiers, , Algeria

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Annaba, , Algeria

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Graz, , Austria

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Innsbruck, , Austria

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Klagenfurt, , Austria

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Linz, , Austria

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Salzburg, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Curitiba, Paraná, Brazil

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Campinas, São Paulo, Brazil

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Beijing, Beijing Municipality, China

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Chonqqing, Chongqing Municipality, China

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Guangzhou, Guangdong, China

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Tianjin, Tianjin Municipality, China

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Hangzhou, Zhejiang, China

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Beijing, , China

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København Ø, , Denmark

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Athens, , Greece

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Thessaloniki, , Greece

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Shatin, New Territories, , Hong Kong

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Budapest, , Hungary

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Debrecen, , Hungary

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Aichi, , Japan

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Hyōgo, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Vilnius, , Lithuania

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Bydgoszcz, , Poland

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Lublin, , Poland

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Porto, , Portugal

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San Juan, , Puerto Rico

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Krasnodar, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Belgrade, , Serbia

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Barcelona, , Spain

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El Palmar, , Spain

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Madrid, , Spain

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Adana, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Bornova-IZMIR, , Turkey (Türkiye)

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İzmit, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Countries

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Czechia United States Algeria Austria Brazil China Denmark Greece Hong Kong Hungary Japan Lithuania Poland Portugal Puerto Rico Russia Serbia Spain Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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