Trial Outcomes & Findings for Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773 (NCT NCT01395810)
NCT ID: NCT01395810
Last Updated: 2018-05-09
Results Overview
The primary endpoint was incidence of inhibitors against coagulation factor nine (FIX) defined as titre ≥0.6 Bethesda unit (BU). Number of subjects who developed inhibitors against FIX are reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
71 participants
Primary outcome timeframe
From Day 1 up to 2 years
Results posted on
2018-05-09
Participant Flow
The trial was conducted at 41 sites in 15 countries as follows: France: 1 site; Germany: 3 sites; Italy: 2 sites; Japan: 4 sites; Macedonia: 2 sites; Malaysia: 1 site; Netherlands: 1 site; Romania: 1 site, Russia: 1 site; South Africa: 1 site; Taiwan: 1 site, Thailand: 2 sites; Turkey: 3 sites; United Kingdom: 5 sites; United States: 13 sites
A total of 71 unique subjects were dosed during this trial. During the trial, subjects were free to switch between treatment arms if agreed between the investigator and the subject. Subjects who switched arms were represented in multiple arms.
Participant milestones
| Measure |
Prophylaxis 10 IU/kg
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an intravenous (i.v.) bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 IU/kg
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 IU/kg
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
48
|
0
|
5
|
|
Overall Study
After Switching the Arms
|
21
|
52
|
2
|
5
|
|
Overall Study
COMPLETED
|
16
|
44
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
0
|
Reasons for withdrawal
| Measure |
Prophylaxis 10 IU/kg
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an intravenous (i.v.) bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 IU/kg
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 IU/kg
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal criteria
|
0
|
2
|
0
|
0
|
|
Overall Study
Unclassified
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
Baseline characteristics by cohort
| Measure |
Prophylaxis 10 IU/kg
n=18 Participants
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 IU/kg
n=48 Participants
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 IU/kg
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
n=5 Participants
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.2 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
31.4 Years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
—
|
37.6 Years
STANDARD_DEVIATION 15.4 • n=4 Participants
|
32.0 Years
STANDARD_DEVIATION 14.2 • n=21 Participants
|
|
Age, Customized
13 - 17 years
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Age, Customized
18 - 70 years
|
15 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
—
|
5 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 2 yearsPopulation: Safety Analysis Set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.
The primary endpoint was incidence of inhibitors against coagulation factor nine (FIX) defined as titre ≥0.6 Bethesda unit (BU). Number of subjects who developed inhibitors against FIX are reported.
Outcome measures
| Measure |
Prophylaxis 10 IU/kg
n=21 Participants
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 IU/kg
n=52 Participants
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 IU/kg
n=2 Participants
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
n=5 Participants
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
Total
Subjects received nonacog beta pegol as prophylaxis treatment or on-demand treatment. Subjects in the prophylaxis treatment received either 10 IU/kg once weekly, 40 IU/kg once weekly or 80 IU/kg once every second week. Subjects in the on-demand group were administered with a single dose of 40 IU/kg of nonacog beta pegol. Subjects with on-demand treatment and prophylaxis treatments who experienced a bleeding episode were to be treated with single dose of 40 IU/kg unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|---|
|
Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units)
|
0 Patients with inhibitory antibodies
|
0 Patients with inhibitory antibodies
|
0 Patients with inhibitory antibodies
|
0 Patients with inhibitory antibodies
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to 2 yearsPopulation: Full analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.
The haemostatic effect was evaluated by a four-point scale where an "excellent" or "good" outcome translated into a successful treatment, and a "moderate" or "poor" outcome was considered a treatment failure. The values mentioned below do not include bleeds with missing response.
Outcome measures
| Measure |
Prophylaxis 10 IU/kg
n=35 Bleeding episodes
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 IU/kg
n=98 Bleeding episodes
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 IU/kg
n=1 Bleeding episodes
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
n=73 Bleeding episodes
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
Total
n=207 Bleeding episodes
Subjects received nonacog beta pegol as prophylaxis treatment or on-demand treatment. Subjects in the prophylaxis treatment received either 10 IU/kg once weekly, 40 IU/kg once weekly or 80 IU/kg once every second week. Subjects in the on-demand group were administered with a single dose of 40 IU/kg of nonacog beta pegol. Subjects with on-demand treatment and prophylaxis treatments who experienced a bleeding episode were to be treated with single dose of 40 IU/kg unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|---|
|
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor)
Success
|
97.1 Percentage of bleeding episodes
|
94.8 Percentage of bleeding episodes
|
100 Percentage of bleeding episodes
|
93.2 Percentage of bleeding episodes
|
94.6 Percentage of bleeding episodes
|
|
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor)
Failure
|
2.9 Percentage of bleeding episodes
|
5.2 Percentage of bleeding episodes
|
0 Percentage of bleeding episodes
|
6.8 Percentage of bleeding episodes
|
5.4 Percentage of bleeding episodes
|
SECONDARY outcome
Timeframe: From Day 1 up to 2 yearsPopulation: Full analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.
Annualized bleeding rate is the total number of bleeding episodes/total exposure time. It is analysed by a Poisson regression model with dose as a factor allowing for over-dispersion and using treatment duration as an offset. Median annualized bleeding rate is the median of individual annualized bleeding rates. Numbers are based on the treatment arm at the time of each bleed.
Outcome measures
| Measure |
Prophylaxis 10 IU/kg
n=21 Participants
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 IU/kg
n=52 Participants
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 IU/kg
n=2 Participants
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
Total
Subjects received nonacog beta pegol as prophylaxis treatment or on-demand treatment. Subjects in the prophylaxis treatment received either 10 IU/kg once weekly, 40 IU/kg once weekly or 80 IU/kg once every second week. Subjects in the on-demand group were administered with a single dose of 40 IU/kg of nonacog beta pegol. Subjects with on-demand treatment and prophylaxis treatments who experienced a bleeding episode were to be treated with single dose of 40 IU/kg unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|---|
|
Number of Bleeding Episodes During Routine Prophylaxis
|
1.36 bleeds/patient/year
Interval 0.0 to 2.23
|
1.00 bleeds/patient/year
Interval 0.0 to 2.03
|
0 bleeds/patient/year
Interval 0.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to 2 yearsPopulation: Full analysis set consisted of all subjects exposed to nonacog beta pegol. This endpoint was analysed only for the prophylaxis arms (i.e.,10 IU/kg, 40 IU/kg). No pre-dose measurements were collected for patients on 80 IU/kg every second week prophylaxis.
During the trial, the pre-dose FIX levels was measured with the one-stage clotting assay. Measurements taken at least 5 days and no more than 10 days after last dose as well as at least 14 days after last bleeding episode were included in this analysis. The mean FIX trough levels were estimated based on the mixed effects model on the log-transformed plasma concentration with subject as a random effect. The mean FIX trough level was presented back-transformed to the natural scale.
Outcome measures
| Measure |
Prophylaxis 10 IU/kg
n=21 Participants
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 IU/kg
n=52 Participants
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 IU/kg
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
Total
Subjects received nonacog beta pegol as prophylaxis treatment or on-demand treatment. Subjects in the prophylaxis treatment received either 10 IU/kg once weekly, 40 IU/kg once weekly or 80 IU/kg once every second week. Subjects in the on-demand group were administered with a single dose of 40 IU/kg of nonacog beta pegol. Subjects with on-demand treatment and prophylaxis treatments who experienced a bleeding episode were to be treated with single dose of 40 IU/kg unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|---|
|
FIX Trough Levels
|
0.098 IU/mL
Interval 0.08 to 0.119
|
0.213 IU/mL
Interval 0.189 to 0.241
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to 2 yearsPopulation: Safety Analysis Set consisted of all subjects who were exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.
AEs were summarized by frequency of events and frequency of patients with any event. Incidence of AEs was expressed as number of AEs per subject years of exposure (total number of events /total time in trial).
Outcome measures
| Measure |
Prophylaxis 10 IU/kg
n=21 Participants
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 IU/kg
n=52 Participants
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 IU/kg
n=2 Participants
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
n=5 Participants
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
Total
Subjects received nonacog beta pegol as prophylaxis treatment or on-demand treatment. Subjects in the prophylaxis treatment received either 10 IU/kg once weekly, 40 IU/kg once weekly or 80 IU/kg once every second week. Subjects in the on-demand group were administered with a single dose of 40 IU/kg of nonacog beta pegol. Subjects with on-demand treatment and prophylaxis treatments who experienced a bleeding episode were to be treated with single dose of 40 IU/kg unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|---|
|
Incidence of Adverse Events (AEs)
|
2.4 Events per subject year of exposure
|
1.9 Events per subject year of exposure
|
0 Events per subject year of exposure
|
3.2 Events per subject year of exposure
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to 2 yearsPopulation: Safety Analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.
AEs were summarized by frequency of events and frequency of patients with any event. Incidence of serious AEs was expressed as number of serious AEs per subject years of exposure (total number of events /total time in trial).
Outcome measures
| Measure |
Prophylaxis 10 IU/kg
n=21 Participants
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 IU/kg
n=52 Participants
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 IU/kg
n=2 Participants
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
n=5 Participants
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
Total
Subjects received nonacog beta pegol as prophylaxis treatment or on-demand treatment. Subjects in the prophylaxis treatment received either 10 IU/kg once weekly, 40 IU/kg once weekly or 80 IU/kg once every second week. Subjects in the on-demand group were administered with a single dose of 40 IU/kg of nonacog beta pegol. Subjects with on-demand treatment and prophylaxis treatments who experienced a bleeding episode were to be treated with single dose of 40 IU/kg unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|---|
|
Incidence of Serious Adverse Events (SAEs)
|
0.1 Events per subject year of exposure
|
0.1 Events per subject year of exposure
|
0 Events per subject year of exposure
|
0 Events per subject year of exposure
|
—
|
Adverse Events
Prophylaxis 10 U/kg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Prophylaxis 40 U/kg
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Prophylaxis 80 U/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
On-demand
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prophylaxis 10 U/kg
n=21 participants at risk
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an intravenous (i.v.) bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 U/kg
n=52 participants at risk
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 U/kg
n=2 participants at risk
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
n=5 participants at risk
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Faecaloma
|
4.8%
1/21 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
Other adverse events
| Measure |
Prophylaxis 10 U/kg
n=21 participants at risk
Subjects were given 10 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an intravenous (i.v.) bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 40 U/kg
n=52 participants at risk
Subjects were given 40 IU/kg weekly nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
Prophylaxis 80 U/kg
n=2 participants at risk
Subjects were dosed with 80 IU/kg every second week. Subjects were free to switch between treatment arms if agreed between the investigator and the subject. Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min. Subjects on prophylaxis who experienced a bleeding episode were to treat the bleeding episode with a single dose of 40 IU/kg, unless the bleeding episode was severe in which case it was to be treated with 80 IU/kg.
|
On-demand
n=5 participants at risk
Subjects in the on-demand group were administered with the single dose of 40 IU/kg of nonacog beta pegol. The recommended dose for treatment of a mild or moderate bleeding episode, for example a joint bleed, was a single dose of 40 IU/kg nonacog beta pegol. If there was no observed effect of 40 IU/kg, the investigator was to be contacted prior to administration of the second dose of 40 IU/kg. The recommended dose for severe bleeds was 80 IU/kg nonacog beta pegol. Subjects were free to switch between treatment arms if agreed between the investigator and the subject.
|
|---|---|---|---|---|
|
Eye disorders
Asthenopia
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
General disorders
Chest discomfort
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
2/21 • Number of events 2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Gastrointestinal disorders
Dental caries
|
9.5%
2/21 • Number of events 2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
1.9%
1/52 • Number of events 2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Infections and infestations
Influenza
|
19.0%
4/21 • Number of events 6 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
General disorders
Influenza like illness
|
4.8%
1/21 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
5.8%
3/52 • Number of events 5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
3/21 • Number of events 5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
7.7%
4/52 • Number of events 5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/5 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
General disorders
Pain
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
1.9%
1/52 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 3 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
General disorders
Swelling
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 3 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/52 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
0.00%
0/2 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
20.0%
1/5 • Number of events 1 • Adverse Events (AEs) from baseline visit (visit 1) and until one week after last treatment with nonacog beta pegol (±2 days) (up to 2 years)
The safety analysis set consists of all patients exposed to nonacog beta pegol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER