Trial Outcomes & Findings for A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B (NCT NCT05365217)
NCT ID: NCT05365217
Last Updated: 2026-01-12
Results Overview
Haemostatic effect of N9-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
From start of treatment (week 0) until end of treatment (up to week 50)
Results posted on
2026-01-12
Participant Flow
This trial was conducted at 15 sites that enrolled participants in 1 country (China mainland).
A total of 30 participants were exposed to trial products, of which 15 participants were in Arm A (on demand/Prophylaxis) treatment group and 15 in Arm B (Prophylaxis) treatment group.
Participant milestones
| Measure |
Arm A: Nonacog Beta Pegol (On-demand, Then Prophylaxis)
Participants received intravenous injections of nonacog beta pegol (on-demand treatment for 28 weeks during treatment period 1, followed by 40 international unit per kilogram (IU/kg) for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect during treatment period 2) until 30 exposure days (EDs) to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
15
|
15
|
|
Treatment Period 1
COMPLETED
|
14
|
15
|
|
Treatment Period 1
NOT COMPLETED
|
1
|
0
|
|
Treatment Period 2
STARTED
|
14
|
15
|
|
Treatment Period 2
COMPLETED
|
14
|
15
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Nonacog Beta Pegol (On-demand, Then Prophylaxis)
Participants received intravenous injections of nonacog beta pegol (on-demand treatment for 28 weeks during treatment period 1, followed by 40 international unit per kilogram (IU/kg) for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect during treatment period 2) until 30 exposure days (EDs) to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|
|
Treatment Period 1
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B
Baseline characteristics by cohort
| Measure |
Arm A: Nonacog Beta Pegol (On-demand, Then Prophylaxis)
n=15 Participants
Participants received intravenous injections of nonacog beta pegol (on-demand treatment for 28 weeks during treatment period 1, followed by 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect during treatment period 2) until 30 exposure days (EDs) to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.9 Years
STANDARD_DEVIATION 7.7 • n=210 Participants
|
26.9 Years
STANDARD_DEVIATION 9.7 • n=19 Participants
|
28.4 Years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=210 Participants
|
15 Participants
n=19 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=210 Participants
|
15 Participants
n=19 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=210 Participants
|
15 Participants
n=19 Participants
|
30 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From start of treatment (week 0) until end of treatment (up to week 50)Population: Results were based on the FAS which included all participants exposed to N9-GP in this trial.
Haemostatic effect of N9-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=215 Bleeding Episodes
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
n=4 Bleeding Episodes
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=43 Bleeding Episodes
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes During on Demand and Prophylaxis (PPX)
Excellent
|
203 Bleeding Episodes
|
3 Bleeding Episodes
|
26 Bleeding Episodes
|
|
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes During on Demand and Prophylaxis (PPX)
Good
|
8 Bleeding Episodes
|
1 Bleeding Episodes
|
16 Bleeding Episodes
|
|
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes During on Demand and Prophylaxis (PPX)
Moderate
|
3 Bleeding Episodes
|
0 Bleeding Episodes
|
1 Bleeding Episodes
|
|
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes During on Demand and Prophylaxis (PPX)
None
|
1 Bleeding Episodes
|
0 Bleeding Episodes
|
0 Bleeding Episodes
|
|
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes During on Demand and Prophylaxis (PPX)
Missing
|
0 Bleeding Episodes
|
0 Bleeding Episodes
|
0 Bleeding Episodes
|
SECONDARY outcome
Timeframe: From start of treatment (week 0) until end of treatment (week 50)Population: Results were based on the FAS which included all participants exposed to N9-GP in this trial.
Number of bleeding episodes per year data is reported. Annualised bleeding rate (ABR) is the number of bleeding episodes per year.
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Number of Treated Bleeding Episodes During Prophylaxis (PPX) Treatment (Arm B Only)
|
3.12 bleeding episodes per year
Interval 0.0 to 4.23
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment (week 0) until end of treatment (up to week 50)Population: Results were based on the FAS which included all participants exposed to N9-GP in this trial.
The mean number of injections of N9-GP used for treatment of a bleed from start to stop of a bleed was reported and it was measured in international units per kilogram per bleed (IU/kg/bleed).
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=215 Bleeding Episodes
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
n=4 Bleeding Episodes
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=43 Bleeding Episodes
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Consumption of Nonacog Beta Pegol for Treatment of Bleeding Episodes
|
42.4 IU/kg per bleed
Standard Deviation 1.1
|
41.9 IU/kg per bleed
Standard Deviation 0.5
|
41.6 IU/kg per bleed
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: From start of treatment (week 0) until end of treatment (week 50)Population: Results were based on the FAS which included all participants exposed to N9-GP in this trial.
The mean consumption of N9-GP for prophylaxis per year per participant was reported and it was measured in international units per kilogram per year (IU/kg/year).
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Consumption of Nonacog Beta Pegol for Prophylaxis (PPX) Treatment (Arm B Only)
|
2212.3 IU/kg per year
Standard Deviation 26.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment (week 0) until end of treatment (week 50)Population: Results were based on the FAS which included all participants exposed to N9-GP in this trial.
Trough levels of FVIII was reported for all participants who received prophylaxis treatment. Chromogenic assay was performed with N9-GP product specific standard (PSS) as a calibrator. The analysis is based on a mixed model on the log transformed plasma FVIII activity with age group as fixed effect and participants as a random effect. The mean trough is presented back-transformed to the natural scale. The estimated mean/average steady state trough level of FVIII over time (all visits from start of treatment (week 0) until end of treatment) was presented. Data is reported for specific treatment in which participants were a part of at any time from week 0 to end of the treatment (EOT) Week 50, not at specific time points assessed from week 0 to EOT.
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
FIX Trough Levels During Prophylaxis (PPX) Treatment (Arm B Only)
|
0.298 International unit per milliliter(IU/mL)
Interval 0.26 to 0.341
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment (week 0) until end of treatment (week 50)Population: Results were based on the FAS which included all participants exposed to N9-GP in this trial.
Number of participants who developed inhibitory antibodies (IA) against FVIII was presented. A participant was said to have FVIII-inhibitors if two consecutive tests, preferably within 2 weeks, were positive (greater than or equal to (≥) 0.6 bethesda unit (BU)). For the calculation of the inhibitor rate the numerator was included for all participants with neutralising antibodies while the denominator was included for all participants with a minimum of 50 exposures plus any participants with less than 50 exposures but with neutralising inhibitor.
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
n=14 Participants
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Number of Participants With Inhibitory Antibodies Against FIX Defined as Titre ≥0.6 Bethesda Units (BU)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of treatment (week 0) until end of treatment (week 50)Population: Results were based on the SAS which included all participants exposed to N9-GP in this trial.
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All presented AEs are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N9-GP administration.
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
n=14 Participants
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Number of Adverse Events (AEs)
|
29 Events
|
6 Events
|
29 Events
|
SECONDARY outcome
Timeframe: From start of treatment (week 0) until end of treatment (week 50)Population: Results were based on the SAS which included all participants exposed to N9-GP in this trial.
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. All presented SAEs are treatment-emergent (any serious adverse events which occurred after trial product administration).
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
n=14 Participants
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Number of Serious Adverse Events (SAEs)
|
1 Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Single-dose: 30±10 minutes post injection at week 0, Steady-state: 30±10 minutes post injection at week 12Population: The Pharmacokinetic (PK) analysis set included sub-set of subjects from FAS who were included for PK assessments. Number analysed = Number of participants with available data for specific timepoints.
The incremental recovery was calculated by subtracting the FVIII activity (IU/mL) measured in plasma at time 0 from that measured at time 30 min after dosing and dividing this difference by the dose injected at time 0 expressed as international units per kilogram (IU/kg) body weight. FVIII activity was measured with a chromogenic assay.
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Incremental Recovery (IR) (Arm B Only)
Week 0
|
0.0182 (IU/mL)/(IU/kg)
Geometric Coefficient of Variation 18.9550
|
—
|
—
|
|
Incremental Recovery (IR) (Arm B Only)
Week 12
|
0.0192 (IU/mL)/(IU/kg)
Geometric Coefficient of Variation 17.2668
|
—
|
—
|
SECONDARY outcome
Timeframe: Single-dose: 30±10 minutes post injection at week 0, Steady-state: 30±10 minutes post injection at week 12Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Here, Number analysed (n) = Number of participants with available data for specific timepoints.
Terminal half life was calculated as ln(2)/λz; where λz is the terminal elimination rate constant. The terminal elimination rate constant was estimated using linear regression on the terminal part of the log (activity) versus time profile.
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Terminal Half-life (t½) (Arm B Only)
Week 0
|
90.868 hour
Geometric Coefficient of Variation 13.535
|
—
|
—
|
|
Terminal Half-life (t½) (Arm B Only)
Week 12
|
90.738 hour
Geometric Coefficient of Variation 21.581
|
—
|
—
|
SECONDARY outcome
Timeframe: Single-dose: 0-168 hours post injection at week 0, Steady-state: 0-168 hours post injection at week 12Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Here, Number analysed (n) = Number of participants with available data for specific timepoints.
Clearance (CL) of drug after intravenous administration was reported. Clearance was calculated using the formula CL= Dose / AUC(0-inf) for single dose and CL= Dose / AUC(0-96) h for steady state.
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Clearance (CL) (Arm B Only)
Week 0
|
0.536 milliliters per hour per kilogram
Geometric Coefficient of Variation 22.143
|
—
|
—
|
|
Clearance (CL) (Arm B Only)
Week 12
|
0.487 milliliters per hour per kilogram
Geometric Coefficient of Variation 26.552
|
—
|
—
|
SECONDARY outcome
Timeframe: Single-dose: 0-168 hours post injection at week 0, Steady-state: 0-168 hours post injection at week 12Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Here, Number analysed (n) = Number of participants with available data for specific timepoints.
Area under the plasma activity versus time profile from time zero to 168 hours (AUC0-168h) was measured.
Outcome measures
| Measure |
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 Participants
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Area Under the Curve (AUC) (Arm B Only)
Week 0
|
51.856 hours*international units per milliliter
Geometric Coefficient of Variation 30.134
|
—
|
—
|
|
Area Under the Curve (AUC) (Arm B Only)
Week 12
|
92.914 hours*international units per milliliter
Geometric Coefficient of Variation 21.725
|
—
|
—
|
Adverse Events
Arm A: Nonacog Beta Pegol (On-demand)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm A: Nonacog Beta Pegol (Prophylaxis)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm B: Nonacog Beta Pegol (Prophylaxis)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Nonacog Beta Pegol (On-demand)
n=15 participants at risk
Participants received intravenous injections of nonacog beta pegol on-demand treatment for 28 weeks.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
n=14 participants at risk
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 participants at risk
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Infections and infestations
Haematoma infection
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
Other adverse events
| Measure |
Arm A: Nonacog Beta Pegol (On-demand)
n=15 participants at risk
Participants received intravenous injections of nonacog beta pegol on-demand treatment for 28 weeks.
|
Arm A: Nonacog Beta Pegol (Prophylaxis)
n=14 participants at risk
Participants received intravenous injections of nonacog beta pegol prophylactic treatment with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds, with additional doses as needed if the initial treatment showed no effect, until 30 EDs to nonacog beta pegol in the entire trial were fulfilled.
|
Arm B: Nonacog Beta Pegol (Prophylaxis)
n=15 participants at risk
Participants received intravenous injections of 40 IU/kg nonacog beta pegol once weekly (prophylactic treatment with nonacog beta pegol at a dose of 40 IU/kg weekly) until 50 EDs (including treatment of breakthrough bleeds) and 50 weeks in the entire trial were fulfilled.
|
|---|---|---|---|
|
Investigations
Fibrin D dimer increased
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Investigations
Blood fibrinogen decreased
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Investigations
Blood fibrinogen increased
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Investigations
C-reactive protein increased
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
40.0%
6/15 • Number of events 6 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
7.1%
1/14 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Infections and infestations
Coronavirus infection
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Number of events 2 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
7.1%
1/14 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 3 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Investigations
Fibrinogen degradation products increased
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 2 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Infections and infestations
Periodontitis
|
13.3%
2/15 • Number of events 2 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Vascular disorders
Phlebitis superficial
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Investigations
Procalcitonin increased
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
7.1%
1/14 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Number of events 2 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
7.1%
1/14 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
7.1%
1/14 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
7.1%
1/14 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Eye disorders
Trichiasis
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
26.7%
4/15 • Number of events 5 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Investigations
Weight increased
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
6.7%
1/15 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
|
Investigations
White blood cell count increased
|
6.7%
1/15 • Number of events 2 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/14 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
0.00%
0/15 • From start of treatment (Week 0) until end of trial (Week 54)
All presented AEs are treatment-emergent adverse events. A TEAE was defined as an event with onset after first N9-GP administration. Results were based on the SAS which included all participants exposed to N9-GP in this trial.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
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