Safety and Efficacy of N8 in Haemophilia A Subjects (guardian™1)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00840086
First received: February 6, 2009
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Africa, Asia, Europe, Japan, Oceania, and North and South America.

The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of recombinant factor VIII (N8) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of N8 in prevention and treatment of bleeding during surgical procedures.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Drug: recombinant factor VIII (N8)
Procedure: Blood drawn for laboratory testing
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects 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 N8 inhibitors [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of adverse events and serious adverse events reported [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: recombinant factor VIII (N8)
Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with N8 at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.
Other Names:
  • NN7008
  • rFVIII
Procedure: Blood drawn for laboratory testing
Blood drawn for laboratory testing

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe haemophilia A (FVIII level less than or equal to 1%)
  • Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
  • Subjects can have elective surgery when at least 5 subjects have been treated with N8 for a bleeding episode and 80% of these subjects have a response rated excellent or good

Exclusion Criteria:

  • Presence of any bleeding disorder in addition to haemophilia A
  • Inhibitor titer greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
  • Abnormal renal function tests
  • Known hypersensitivity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840086

  Show 24 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Sofia Jonhede Novo Nordisk A/S
Study Director: Anne Vedsø Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00840086     History of Changes
Other Study ID Numbers: NN7008-3543, 2008-003960-20, 101151
Study First Received: February 6, 2009
Last Updated: June 29, 2012
Health Authority: Israel: Ministry of Health
Italy: The Italian Medicines Agency
Switzerland: Swissmedic
Brazil: National Health Surveillance Agency
Germany: Paul-Ehrlich-Institut
Turkey: Ministry of Health Drug and Pharmaceutical Department
Spain: Spanish Agency of Medicines and Health Care Products
United States: Food and Drug Administration
Serbia: Medicines and Medical Devices Agency of Serbia
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Japan: Pharmaceuticals and medical devices agency (PMDA)
Taiwan: Department of Health, Executive Yuan, R.O.C.
Russia: Federal Service for Control of Health Care and Social Development
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Malaysia: Ministry of Health

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
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 August 26, 2014