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
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| ClinicalTrials.gov Identifier: NCT00984126 |
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Recruitment Status :
Completed
First Posted : September 25, 2009
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
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Brief Summary:
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.
The 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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Congenital Bleeding Disorder Haemophilia A | Drug: turoctocog alfa | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 214 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Actual Study Start Date : | October 26, 2009 |
| Actual Primary Completion Date : | June 28, 2016 |
| Actual Study Completion Date : | June 29, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hemophilia
Drug Information available for:
Turoctocog alfa
| Arm | Intervention/treatment |
|---|---|
| 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) |
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 ]The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial. This endpoint was measured during the trial.
Secondary Outcome Measures :
- Frequency of Adverse Events and Serious Adverse Events [ Time Frame: After 90 months ]The number of adverse events and serious adverse events reported during the main trial and the on-demand sub-trial (during 90 months).
- Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen) [ Time Frame: After 90 months ]The number of bleeding episodes per year reported during the prevention period (during 90 months).
- Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds. [ Time Frame: After 90 months ]Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds using a four-point response scale: none, moderate, good or excellent. The evaluation was done by patient, caregiver and/or investigator based on experience as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an infusion, but possibly requiring more than 1 infusion for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first infusion; usually requiring more than 1 infusion. 4. None: No improvement, or worsening of symptoms. This endpoint is measured during the preventive and on-demand sub-trial (during 90 months).
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| Ages Eligible for Study: | 6 Months to 70 Years (Child, Adult, Older Adult) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984126
Locations
Show 57 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications of Results:
Publications of Results:
Ozelo M, Misgav M, Abdul-Karim F, Lentz S, Martin-Salces M, Matytsina I, Saugstrup T, Santagostino E. Stabilization of turoctocog alfa dose administered in a preventive regimen: 3-year interim results of the guardianTM-2 extension trial. Haemophilia - Special Issue: Abstracts of the WFH 2014 World Congress, May 11-15, Melbourne, Australia; 20 (3): 1-200
Recht M, Lentz S, Zupancic-Salek S, Matytsina I, Landorph A, Saugstrup T. Factor VIII Dosing and Preventive Efficacy in Obese Patients with Hemophilia (BMI =30 kg/m2) - a Post-Hoc Sub-Analysis of the guardian™ Trials. American Society of Hematology - 56th Annual Meeting (ASH); Country: US City: San Francisco, CA
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00984126 |
| Other Study ID Numbers: |
NN7008-3568 2008-005945-46 ( EudraCT Number ) U1111-1111-9377 ( Other Identifier: WHO ) JapicCTI-101357 ( Registry Identifier: JAPIC ) |
| First Posted: | September 25, 2009 Key Record Dates |
| Results First Posted: | July 27, 2017 |
| Last Update Posted: | July 27, 2017 |
| Last Verified: | June 2017 |
Additional relevant MeSH terms:
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Hemostatic Disorders Hemophilia A Blood Coagulation Disorders Hemorrhage Pathologic Processes Blood Coagulation Disorders, Inherited Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Vascular Diseases Cardiovascular Diseases Factor VIII Coagulants |