Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A (pathfinder™3)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by Novo Nordisk A/S
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01489111
First received: November 23, 2011
Last updated: September 20, 2016
Last verified: September 2016
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Purpose
This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Bleeding Disorder Haemophilia A |
Drug: turoctocog alfa pegol |
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: | Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
MedlinePlus related topics:
Hemophilia
U.S. FDA Resources
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Haemostatic effect during surgery evaluated by the four-point scale (excellent, good, moderate or none) [ Time Frame: Assessed by the Investigator/surgeon at the day of surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average consumption of N8-GP [ Time Frame: During surgery ] [ Designated as safety issue: No ]
- Haemostatic effect of N8-GP evaluated by the four-point scale (excellent, good, moderate or none) [ Time Frame: During the post-operative period, days 1-14 ] [ Designated as safety issue: No ]
- Average consumption of N8-GP [ Time Frame: During the post-operative period, days 1-6 ] [ Designated as safety issue: No ]
- Incidence rate of inhibitors against factor VIII (FVIII) (at least 0.6 BU (Bethesda Units)/mL) [ Time Frame: Up to approximately 5 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 43 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Surgery |
Drug: turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Other Name: NNC 0129-0000-1003
|
Eligibility| Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP
- Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and wound status for at least 3 days
- The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes and otherwise capable of following the trial procedures
Exclusion Criteria:
- Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
- Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial after administration of trial product, except interruption due to inclusion in this pathfinderTM 3 trial (NN7088-3860)
- The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial. (For Brazil, only: Participation in a previous clinical trial within one year prior to screening for this trial (Visit 1), unless there is a direct benefit to the research subject, at the Investigator's discretion)
- FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening
- Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
- Immune modulating or chemotherapeutic medication
- Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's judgement, could imply a potential hazard to the patient, interfere with trial participation or trial outcome
- Unwillingness, language or other barriers precluding adequate understanding and/or cooperation
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: NCT01489111
Show 30 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489111
Contacts
| Contact: Novo Nordisk | clinicaltrials@novonordisk.com |
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:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01489111 History of Changes |
| Other Study ID Numbers: | NN7088-3860 U1111-1119-7326 2011-001144-30 132215 |
| Study First Received: | November 23, 2011 |
| Last Updated: | September 20, 2016 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Croatia: Ministry of Health and Social Care Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Hungary: Ministry of Health, Social and Family Affairs Italy: AIFA, National Medicines Agency Japan: Ministry of Health, Labour and Welfare (MHLW) Malaysia: Drug Control Authority (DCA) Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate Turkey: Ministry of Health Drug and Pharmaceutical Department United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hemophilia A Blood Coagulation Disorders Hemostatic Disorders Blood Coagulation Disorders, Inherited Hematologic Diseases Coagulation Protein Disorders |
Hemorrhagic Disorders Genetic Diseases, Inborn Vascular Diseases Cardiovascular Diseases Factor VIII Coagulants |
ClinicalTrials.gov processed this record on September 30, 2016