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Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00984126
First received: September 21, 2009
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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

The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.

This trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Drug: turoctocog alfa
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: Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Frequency of development of FVIII inhibitors (greater than or equal to 0.6 Bethesda Units (BU)/mL) [ Time Frame: after 90 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interest (MESIs) reported [ Time Frame: after 90 months ] [ Designated as safety issue: Yes ]
  • Average number of bleeds per month reported during the prevention period [ Time Frame: after 90 months ] [ Designated as safety issue: No ]
  • Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds. [ Time Frame: after 90 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 214
Study Start Date: October 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Turoctocog alfa Drug: turoctocog alfa
The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
Drug: turoctocog alfa
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)

  Eligibility

Ages Eligible for Study:   6 Months to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent obtained before any trial-related activities
  • Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015

Exclusion Criteria:

  • Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product
  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: NCT00984126

  Show 30 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00984126     History of Changes
Other Study ID Numbers: NN7008-3568, 2008-005945-46, U1111-1111-9377, JapicCTI-101357
Study First Received: September 21, 2009
Last Updated: August 14, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish agency of medicines and health care products
Switzerland: Swissmedic
Brazil: National Health Surveillance Agency
Israel: Ministry of Health
Russia: Federal Service for Control of Health Care and Social Development
Croatia: Ministry of Health and Social Care
Serbia: Medicines and Medical Devices Agency of Serbia
United States: Food and Drug Administration
Turkey: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and medical devices agency (PMDA)
Taiwan: Department of Health, Executive Yuan, R.O.C.
Turkey: Ministry of Health Drug and Pharmaceutical Department
Malaysia: Ministry of Health
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Lithuania: Lithuanian Bioethics Committee
Latvia: Ministry of Health

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

ClinicalTrials.gov processed this record on November 25, 2014