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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03528551
Other study ID # NN7088-4410
Secondary ID U1111-1202-27802
Status Completed
Phase Phase 3
First received
Last updated
Start date April 30, 2018
Est. completion date December 3, 2020

Study information

Verified date December 2022
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 3, 2020
Est. primary completion date December 3, 2020
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: - Male patients of all ages with the diagnosis of severe congenital haemophilia A (coagulation Factor VIII [FVIII] activity less than 1%) based on medical records - On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at the time of transfer Exclusion Criteria: - Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products - Any disorder, except for conditions associated with haemophilia, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol - Current participation in any clinical trial (except NN7088-3859 (pathfinder2) or NN7088-3885 (pathfinder5)) of an approved or non-approved investigational medicinal product

Study Design


Intervention

Drug:
Turoctocog alfa pegol
Turoctocog alfa pegol 75 IU/kg body weight will be administered once weekly as intravenous injections for a duration of 2 years.
Turoctocog alfa pegol
Turoctocog alfa pegol 60 IU/kg body weight (for patients younger than 12 years) and 50 IU/kg body weight (for patients, 12 years or older) will be administered twice weekly as intravenous injections for a duration of 2 years.
Turoctocog alfa pegol
Turoctocog alfa pegol 50 IU/kg body weight will be administered three times weekly as intravenous injections for a duration of 2 years.

Locations

Country Name City State
Australia Novo Nordisk Investigational Site Camperdown New South Wales
Australia Novo Nordisk Investigational Site Parkville Victoria
Brazil Novo Nordisk Investigational Site Campinas Sao Paulo
Canada Novo Nordisk Investigational Site Toronto Ontario
Croatia Novo Nordisk Investigational Site Zagreb
Denmark Novo Nordisk Investigational Site Århus N
France Novo Nordisk Investigational Site Bron Cedex
France Novo Nordisk Investigational Site Le Kremlin Bicetre
France Novo Nordisk Investigational Site Nantes Cedex 1
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Frankfurt/M.
Germany Novo Nordisk Investigational Site Homburg
Greece Novo Nordisk Investigational Site Athens
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Debrecen
Israel Novo Nordisk Investigational Site Tel-Hashomer
Italy Novo Nordisk Investigational Site Milano
Italy Novo Nordisk Investigational Site Vicenza
Japan Novo Nordisk Investigational Site Kitakyusyu-shi, Fukuoka
Japan Novo Nordisk Investigational Site Nara
Japan Novo Nordisk Investigational Site Tokyo
Korea, Republic of Novo Nordisk Investigational Site Daejeon
Lithuania Novo Nordisk Investigational Site Vilnius
Malaysia Novo Nordisk Investigational Site Selangor Darul Ehsan
Netherlands Novo Nordisk Investigational Site Groningen
Netherlands Novo Nordisk Investigational Site Rotterdam
Norway Novo Nordisk Investigational Site Oslo
Portugal Novo Nordisk Investigational Site Porto
Puerto Rico Novo Nordisk Investigational Site San Juan
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Málaga
Switzerland Novo Nordisk Investigational Site Bellinzona
Switzerland Novo Nordisk Investigational Site Lausanne
Switzerland Novo Nordisk Investigational Site Zürich
Switzerland Novo Nordisk Investigational Site Zürich
Taiwan Novo Nordisk Investigational Site Taipei
Turkey Novo Nordisk Investigational Site Adana
Turkey Novo Nordisk Investigational Site Antalya
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
Turkey Novo Nordisk Investigational Site Izmit
Turkey Novo Nordisk Investigational Site Samsun
Ukraine Novo Nordisk Investigational Site Lviv
United Kingdom Novo Nordisk Investigational Site Basingstoke
United Kingdom Novo Nordisk Investigational Site Cardiff
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Oxford
United Kingdom Novo Nordisk Investigational Site Oxford
United Kingdom Novo Nordisk Investigational Site Sheffield
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Charleston South Carolina
United States Novo Nordisk Investigational Site Charlotte North Carolina
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Dayton Ohio
United States Novo Nordisk Investigational Site Detroit Michigan
United States Novo Nordisk Investigational Site East Lansing Michigan
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Long Beach California
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site Nashville Tennessee
United States Novo Nordisk Investigational Site New Hyde Park New York
United States Novo Nordisk Investigational Site New Orleans Louisiana
United States Novo Nordisk Investigational Site Norfolk Virginia
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Croatia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Malaysia,  Netherlands,  Norway,  Portugal,  Puerto Rico,  Spain,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events Reported An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAEs). The TEAE is defined as an event reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). Week 0 to week 108
Secondary Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) =0.6 Bethesda Units (BU) The Incidence of inhibitors against coagulation factor eight (FVIII) is defined as titre greater than or equal to (=) 0.6 Bethesda unit. The inhibitor antibodies were measured using a heat modified Nijmegen FVIII Bethesda assay. The number of participants who developed inhibitors against FVIII are reported. Week 0 to week 104
Secondary Number of Bleeding Episodes on Prophylaxis Number of bleeding episodes per participant in the prophylaxis regimen was evaluated during 104 weeks. Week 0 to week 104
Secondary Number of Spontaneous Bleeding Episodes on Prophylaxis Spontaneous bleeding referred as bleeding episodes that occurred without apparent cause. The number of spontaneous bleeding episodes were evaluated during 104 weeks. Week 0 to week 104
Secondary Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None The haemostatic effect after treatment of a bleed with N8-GP was assessed using a 4-point scale: 'excellent', 'good', 'moderate' or 'none'. The evaluation was done as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single injection. 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection; usually requiring more than one injection 4. None: No improvement or worsening of symptoms. Week 0 to week 104
Secondary Mean Number of N8-GP Injections Required Per Bleeding Episode The mean number of N8-GP injections required per bleeding episode from start to stop of a bleed for participants was presented from week 0 to week 104. Week 0 to week 104
Secondary Pre-dose FVIII Activity Levels on N8-GP Prophylaxis The pre-dose FVIII activity levels were assessed in International units per millilitre (IU/mL) units from week 0 to week 104 to get an estimate of the pre-dose level for N8-GP at steady-state using mixed model. Week 0 to week 104
Secondary Change in Joint Health Status From Start to End of Trial (Based on Haemophilia Joint Health Score) Haemophilia Joint Health Score is a validated outcome tool developed for the assessment of joint health in patients with hemophilia. It comprises an evaluation of the elbow, knee and ankle joints with regards to swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. Higher the score higher the joint damage). Change from week 0 to end of trial (week 104) in the domain scores was presented. Week 0, Week 104
Secondary Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None The Haemostatic response to N8-GP during major surgical interventions was assessed using a 4-point scale: 'excellent', 'good', 'moderate' or 'none'. The evaluation was done as follows: 1. Excellent: Better than expected/predicted in this type of procedure. 2. Good: As expected in this type of procedure 3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen 4. None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required. This endpoint was measured from week 0 to week 104. Week 0 to week 104
Secondary Consumption of N8-GP Per Bleed The average dose of N8-GP consumed for treatment of bleed was assessed in International units per kilogram per bleed(IU/kg/bleed). This endpoint was evaluated from week 0 to week 104. Week 0 to week 104
Secondary Consumption of N8-GP During Prophylaxis Treatment The average dose of N8-GP consumed for prevention of bleed was assessed. This endpoint was evaluated from week 0 to week 104. Week 0 to week 104
Secondary Change From Start Till End of Trial in Treatment Satisfaction (Based on Hemo-SAT Score) The treatment satisfaction of a bleed with N8-GP was assessed using HEMO-SAT assessment tool which contains a questionnaire with 6 domains (Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction), with a scale of 0-100. The lower scores reflecting greater treatment satisfaction. In other words, decrease in the score would mean improvement. The summary of change presented was based on individual changes since week 0. Data is presented for total score. Week 0, Week 104
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