A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

Brief Title

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

Official Title

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

Brief Summary

      This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and
      pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP)
      in children with severe haemophilia A who have undergone treatment with previous factor VIII
      (FVIII) products.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units

Secondary Outcome

 Frequency of Adverse Events Including Serious Adverse Events Reported During the Trial Period

Condition

Congenital Bleeding Disorder

Intervention

turoctocog alfa pegol

Study Arms / Comparison Groups

 N8-GP

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

February 20, 2013

Completion Date

September 28, 2018

Primary Completion Date

September 15, 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Male patients with severe congenital haemophilia A (FVIII activity level below 1%)

          -  Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII
             products for patients aged 6-11 years and above 50 ED to FVIII products for patients
             aged 0-5 years

        Exclusion Criteria:

        - Any history of FVIII inhibitors

Gender

Male

Ages

0 Years - 11 Years

Accepts Healthy Volunteers

No

Contacts

Global Clinical Registry (GCR, 1452), ,

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT01731600

Organization ID

NN7088-3885

Secondary IDs

U1111-1129-6009

Responsible Party

Sponsor

Study Sponsor

Novo Nordisk A/S

Study Sponsor

Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

Verification Date

November 2020