Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A. (pathfinder™3)

• ClinicalTrials.gov Identifier: NCT01489111
• Recruitment Status: Completed
• First Posted: December 9, 2011
• Last Update Posted: February 18, 2019
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Congenital Bleeding Disorder; Haemophilia A	Drug: turoctocog alfa pegol	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
• Actual Study Start Date: August 3, 2012
• Actual Primary Completion Date: December 10, 2018
• Actual Study Completion Date: December 10, 2018

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Average consumption of N8-GP [ Time Frame: During surgery ]
2. 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 ]
3. Average consumption of N8-GP [ Time Frame: During the post-operative period, days 1-6 ]
4. Incidence rate of inhibitors against factor VIII (FVIII) (at least 0.6 BU (Bethesda Units)/mL) [ Time Frame: Up to approximately 5 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes 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

  Show 70 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:

Clinical Trials at Novo Nordisk 

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01489111 History of Changes
• Other Study ID Numbers: NN7088-3860; U1111-1119-7326 ( Other Identifier: WHO ); 2011-001144-30 ( EudraCT Number ); 132215 ( Other Identifier: JapicCTI )
• First Posted: December 9, 2011
• Last Update Posted: February 18, 2019
• Last Verified: February 2019

Additional relevant MeSH terms:

Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Blood Coagulation Disorders, Inherited; Hematologic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Vascular Diseases; Cardiovascular Diseases; Factor VIII; Coagulants