Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

Novo Nordisk A/S13 enrolled

Overview

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia B

Interventions

nonacog beta pegolDRUG

The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).

Eligibility

Sex: MALEMin age: 13 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with haemophilia B with a FIX activity below or equal to 2% * Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records * History of at least 150 exposure days to other FIX products * Scheduled major surgery Exclusion Criteria: * Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews * Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (central laboratory) * 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) * ALT (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory) * Immune modulating or chemotherapeutic medication

Locations (41)

Outcomes

Primary Outcomes

Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)

Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale: \- Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience 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. Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.

Time frame: At the day of surgery

Secondary Outcomes

Consumption of NNC-0156-0000-0009 (U/kg Body Weight)

Mean consumption of nonacog beta pegol (U/kg) used for treatment per patient before surgery, during surgery (the time from knife to skin until last stitch) and post-operative period.

Time frame: During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)

Transfusion Requirements (Fulfilling Transfusion Criteria)

Mean quantity of transfusion during surgery (the time from knife to skin until last stitch) and the postoperative period (Day 1-13).None of the patients required transfusions beyond Day 6 hence no values presented for days 7-13.

Time frame: during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)

Haemoglobin Pre- and Post-surgery Start

The mean pre-surgery and post surgery haemoglobin level.

Time frame: 0, 1 hour, 24 hours.

Incidence of Adverse Events (AEs)

The number of adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.

Data from ClinicalTrials.gov

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