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.
Verified April 2013 by Novo Nordisk
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01489111
First received: November 23, 2011
Last updated: April 29, 2013
Last verified: April 2013
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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: NNC 0129-0000-1003 |
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:
Further study details as provided by Novo Nordisk:
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: | 18 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Surgery |
Drug: NNC 0129-0000-1003
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489111
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Contacts
| Contact: Novo Nordisk | clinicaltrials@novonordisk.com |
Show 42 Study LocationsSponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Kristine Beisner | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01489111 History of Changes |
| Other Study ID Numbers: | NN7088-3860, U1111-1119-7326, 2011-001144-30 |
| Study First Received: | November 23, 2011 |
| Last Updated: | April 29, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Brazil: National Health Surveillance Agency Croatia: Ministry of Health and Social Care Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: BfArM and Paul-Ehrlich Institute (PEI) 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 Norway: Norwegian Medicines Control Authority South Korea: Korea Food and Drug Administration (KFDA) Spain: Spanish Agency of Medicines and Health Care Products Sweden: Medical Products Agency Switzerland: Federal Office of Public Health Taiwan: Department of Health, Executive Yuan, R.O.C. Turkey: Ministry of Health Drug and Pharmaceutical Department United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA) United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemophilia A 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 May 19, 2013