Safety and Efficacy of Recombinant Factor VIII (N8) in Previously Treated Male Children With Haemophilia A (guardian™ 3)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01138501
First received: May 28, 2010
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Asia, Europe, Japan and the United States of America (USA).

The aim of this clinical trial is to investigate the safety and efficacy of N8 in male previously treated paediatric subjects with haemophilia A.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Drug: recombinant factor VIII (N8)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • The incidence rate of factor VIII inhibitors (0.6 Bethesda Units (BU)/mL or above) [ Time Frame: reported at all visits from trial start (visit 1) to end of trial (visit 8) with a time interval of 28 ± 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of serious adverse events (SAE) [ Time Frame: reported at all visits from trial start (visit 1) to end of trial (visit 8) with a time interval of 28 ± 4 days ] [ Designated as safety issue: No ]
  • Frequency of adverse events (AEs) [ Time Frame: reported at all visits from trial start (visit 1) to end of trial (visit 8) with a time interval of 28 ± 4 days ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preventive treatment Drug: recombinant factor VIII (N8)
Subjects will be treated 3 times per week or every second day with intravenous injections of N8. The dose range for preventive treatment is 25-60 IU/kg body weight every depending on treatment regimen
Experimental: Pharmacokinetic/preventive treatment Drug: recombinant factor VIII (N8)
Subjects will undergo half life evaluation of their current factor VIII product and pharmacokinetic session with N8 before entering preventive treatment. Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients with severe haemophilia A
  • Weight at least 11 kg

Exclusion Criteria:

  • Surgery planned to occur during trial participation
  • Congenital or acquired coagulation disorders other than haemophilia A
  • No history of inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138501

  Show 20 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Rikke Zillmer Novo Nordisk A/S
Study Director: Elisabeth Lynge Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01138501     History of Changes
Obsolete Identifiers: NCT01250028
Other Study ID Numbers: NN7008-3545, U1111-1113-7182, 2009-016383-36
Study First Received: May 28, 2010
Last Updated: June 29, 2012
Health Authority: Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Lithuania: Lithuanian Bioethics Committee
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Malaysia: Ministry of Health
Poland: Ministry of Health
Russia: Federal Service for Control of Health Care and Social Development
Serbia: Agency for Drugs and Medicinal Devices
Taiwan: Department of Health
Turkey: Ministry of Health
United States: Food and Drug Administration
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia A
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014