Trial Outcomes & Findings for Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10) (NCT NCT05082116)
NCT ID: NCT05082116
Last Updated: 2024-12-16
Results Overview
Number of bleeding episodes per year (Annualised Bleeding Rate) data is reported. Annualised bleeding rate (ABR) is the number of bleeding episodes per year.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
From start of treatment (Week 0) until Week 28
Results posted on
2024-12-16
Participant Flow
A total of 36 Chinese participants with a severe haemophilia A were recruited in this trial. The trial was conducted at 8 sites in China mainland.
Participant milestones
| Measure |
Adolescents (12-17 Years)
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
23
|
|
Overall Study
Full Analysis Set
|
13
|
23
|
|
Overall Study
Safety Analysis Set
|
13
|
23
|
|
Overall Study
Pharmacokinetic (PK) Analysis Set
|
4
|
11
|
|
Overall Study
COMPLETED
|
13
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10)
Baseline characteristics by cohort
| Measure |
Adolescents (12-17 Years)
n=13 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=23 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.7 Years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
28.7 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
23.3 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment (Week 0) until Week 28Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.
Number of bleeding episodes per year (Annualised Bleeding Rate) data is reported. Annualised bleeding rate (ABR) is the number of bleeding episodes per year.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=13 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=23 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Number of Bleeding Episodes Per Year (Annualised Bleeding Rate)
|
0.00 Bleeding episodes per year
Interval 0.0 to 1.63
|
0.00 Bleeding episodes per year
Interval 0.0 to 1.83
|
SECONDARY outcome
Timeframe: From start of treatment (Week 0) until Week 28Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.
Haemostatic effect of N8-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 |
Adolescents (12-17 Years)
n=13 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=23 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None)
Excellent
|
18 Bleeding Episodes
|
22 Bleeding Episodes
|
|
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None)
Good
|
3 Bleeding Episodes
|
6 Bleeding Episodes
|
|
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None)
Moderate
|
3 Bleeding Episodes
|
0 Bleeding Episodes
|
|
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None)
None
|
0 Bleeding Episodes
|
0 Bleeding Episodes
|
|
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None)
Missing
|
0 Bleeding Episodes
|
0 Bleeding Episodes
|
SECONDARY outcome
Timeframe: From start of treatment (Week 0) until Week 28Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.
The mean number of injections of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=24 Bleeding episodes
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=28 Bleeding episodes
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Number of Injections Needed to Treat Bleeding Episodes
|
2 Injections per bleed
Standard Deviation 0.8
|
1 Injections per bleed
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: From start of treatment (Week 0) until Week 28Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.
The mean consumption of N8-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 |
Adolescents (12-17 Years)
n=13 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=23 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Consumption of N8-GP for Prophylaxis
|
4909.5 IU/kg/year
Standard Deviation 252.0
|
4873.9 IU/kg/year
Standard Deviation 237.6
|
SECONDARY outcome
Timeframe: From start of treatment (Week 0) (excluding the first exposure) until Week 28Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.
Trough levels of FVIII was reported for all participnats who received prophylaxis treatment. Chromogenic assay was performed with N8-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 participant as a random effect. The mean trough is presented back-transformed to the natural scale.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=13 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=23 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
FVIII Trough Activity During Prophylaxis
|
0.032 International unit per milliliter(IU/mL)
Interval 0.023 to 0.044
|
0.034 International unit per milliliter(IU/mL)
Interval 0.025 to 0.045
|
SECONDARY outcome
Timeframe: From start of treatment (Week 0) until Week 28Population: Results were based on the FAS which included all participants exposed to N8-GP in this trial.
Percentage of participants who developed inhibitory antibodies 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 |
Adolescents (12-17 Years)
n=13 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=23 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Percentage of Participants With Incidence Rate of Confirmed FVIII Inhibitors ≥0.6 BU
|
0.00 Percentage of participants
|
0.00 Percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment (Week 0) until end of trial (Week 32)Population: Results were based on the safety analysis set (SAS) which included all participants exposed to N8-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 N8-GP administration.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=13 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=23 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Number of Adverse Events (AEs)
|
15 Events
|
25 Events
|
SECONDARY outcome
Timeframe: From start of treatment (Week 0) until end of trial (Week 32)Population: Results were based on the SAS which included all participants exposed to N8-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 |
Adolescents (12-17 Years)
n=13 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=23 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Number of Serious Adverse Events (SAEs)
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: 30 min post-injection at Week 0, Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = 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 IU/kg body weight. FVIII activity was measured with a chromogenic assay.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Incremental Recovery (IR)
Week 0
|
0.023 (IU/mL)/(IU/kg)
Geometric Coefficient of Variation 28.107
|
0.023 (IU/mL)/(IU/kg)
Geometric Coefficient of Variation 28.367
|
|
Incremental Recovery (IR)
Week 28
|
0.029 (IU/mL)/(IU/kg)
Geometric Coefficient of Variation 1.443
|
0.024 (IU/mL)/(IU/kg)
Geometric Coefficient of Variation 23.535
|
SECONDARY outcome
Timeframe: 30 min post-injection at Week 0, Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = Number of participants with available data for specific timepoints.
FVIII plasma activity was measured after 30 mins of injection. FVIII activity was measured with a chromogenic assay.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
FVIII Activity 30 Min Post-injection (C30min)
Week 0
|
1.178 IU/mL
Geometric Coefficient of Variation 24.531
|
1.196 IU/mL
Geometric Coefficient of Variation 27.304
|
|
FVIII Activity 30 Min Post-injection (C30min)
Week 28
|
1.557 IU/mL
Geometric Coefficient of Variation 0.646
|
1.302 IU/mL
Geometric Coefficient of Variation 21.521
|
SECONDARY outcome
Timeframe: Single-dose: 96 h ± 8 h post-injection at Week 0, Steady-state: 96 h ± 8 h post-injection at Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = Number of participants with available data for specific timepoints.
FVIII plasma activity was measured after 96 h of injection. This was measured at two time points Week 0 and Week 28 during the study. Chromogenic assay was performed.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
FVIII Trough Activity 96 h Post-injection (C96h)
Week 0
|
0.033 IU/mL
Geometric Coefficient of Variation 36.048
|
0.039 IU/mL
Geometric Coefficient of Variation 44.608
|
|
FVIII Trough Activity 96 h Post-injection (C96h)
Week 28
|
0.032 IU/mL
Geometric Coefficient of Variation 14.616
|
0.045 IU/mL
Geometric Coefficient of Variation 58.020
|
SECONDARY outcome
Timeframe: 0-96 hours post-injection at Week 0 and Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = Number of participants with available data for specific timepoints.
Area under the plasma activity versus time profile from time zero to infinity (AUC0-inf) was measured.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Area Under the Curve (AUC0-inf)
Week 0
|
31.556 h*(IU/mL)
Geometric Coefficient of Variation 20.100
|
33.650 h*(IU/mL)
Geometric Coefficient of Variation 26.123
|
|
Area Under the Curve (AUC0-inf)
Week 28
|
37.274 h*(IU/mL)
Geometric Coefficient of Variation 4.541
|
37.952 h*(IU/mL)
Geometric Coefficient of Variation 28.030
|
SECONDARY outcome
Timeframe: 0-96 hours post-injection at Week 0 and Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = Number of participants with available data for specific timepoints.
Area under the plasma activity versus time profile from time zero to last measurable activity (AUC0-t) was measured.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Area Under the Curve (0-t)
Week 0
|
30.578 h*(IU/mL)
Geometric Coefficient of Variation 19.999
|
32.300 h*(IU/mL)
Geometric Coefficient of Variation 26.565
|
|
Area Under the Curve (0-t)
Week 28
|
36.467 h*(IU/mL)
Geometric Coefficient of Variation 4.292
|
36.406 h*(IU/mL)
Geometric Coefficient of Variation 27.173
|
SECONDARY outcome
Timeframe: 0-96 hours post-injection at Week 0 and Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = Number of participants with available data for specific timepoints.
Area under the plasma activity versus time profile from time zero to 96 hours (AUC0-96h) was measured.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Area Under the Curve (0-96h)
Week 28
|
36.428 h*(IU/mL)
Geometric Coefficient of Variation 4.251
|
36.398 h*(IU/mL)
Geometric Coefficient of Variation 27.168
|
|
Area Under the Curve (0-96h)
Week 0
|
30.509 h*(IU/mL)
Geometric Coefficient of Variation 19.989
|
32.269 h*(IU/mL)
Geometric Coefficient of Variation 26.558
|
SECONDARY outcome
Timeframe: 0-96 hours post-injection on Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Overall number of partianalyzed = Number of participants with available data.
Accumulation ratio was calculated as AUC(0-96h) at steady state/AUC(0-96h) at single dose. AUC(0-96) is the area under the plasma activity versus time profile from time zero to 96 hours.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=3 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=10 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Accumulation Ratio
|
1.152 Ratio of AUC
Geometric Coefficient of Variation 19.682
|
1.086 Ratio of AUC
Geometric Coefficient of Variation 53.085
|
SECONDARY outcome
Timeframe: 0-96 hours post-injection on Week 0 and Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = 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 |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Terminal Half-life (t½)
Week 0
|
19.106 hour (h)
Geometric Coefficient of Variation 14.019
|
20.200 hour (h)
Geometric Coefficient of Variation 20.422
|
|
Terminal Half-life (t½)
Week 28
|
17.729 hour (h)
Geometric Coefficient of Variation 5.568
|
20.238 hour (h)
Geometric Coefficient of Variation 18.882
|
SECONDARY outcome
Timeframe: Single-dose: 0-96 h post-injection at Week 0, Steady-state: 0-96 h post-injection at Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = 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 |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Clearance (CL)
Week 0
|
1.636 milliter per hour per kilogram (mL/h/kg)
Geometric Coefficient of Variation 17.092
|
1.550 milliter per hour per kilogram (mL/h/kg)
Geometric Coefficient of Variation 29.123
|
|
Clearance (CL)
Week 28
|
1.434 milliter per hour per kilogram (mL/h/kg)
Geometric Coefficient of Variation 4.488
|
1.434 milliter per hour per kilogram (mL/h/kg)
Geometric Coefficient of Variation 25.335
|
SECONDARY outcome
Timeframe: 0-96 hours post-injection on Week 0 and Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = Number of participants with available data for specific timepoints.
Apparent volume of distribution (Vz) based on the terminal phase was measured. Apparent volume of distribution was calculated using formula: total plasma clearance divided by terminal elimination rate constant (Vz= CL/λz).
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz) Based on the Terminal Phase
Week 0
|
45.098 milliter per kilogram (mL/kg)
Geometric Coefficient of Variation 24.375
|
45.165 milliter per kilogram (mL/kg)
Geometric Coefficient of Variation 34.649
|
|
Apparent Volume of Distribution (Vz) Based on the Terminal Phase
Week 28
|
36.673 milliter per kilogram (mL/kg)
Geometric Coefficient of Variation 4.042
|
41.878 milliter per kilogram (mL/kg)
Geometric Coefficient of Variation 27.534
|
SECONDARY outcome
Timeframe: 0-96 h post-injection at Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Overall number of partianalyzed = Number of participants with available data.
Apparent volume of distribution (Vss) at steady-state was measured. Apparent volume of distribution (Vss) was calculated using formula: total plasma clearance multiplied by mean residence time (Vss=CL\*MRT).
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=3 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Apparent Volume of Distribution (Vss) Based on Steady-state
|
34.511 milliter per kilogram (mL/kg)
Geometric Coefficient of Variation 5.727
|
39.786 milliter per kilogram (mL/kg)
Geometric Coefficient of Variation 28.558
|
SECONDARY outcome
Timeframe: 0-96 hours post-injection on Week 0 and Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = Number of participants with available data for specific timepoints.
Percentage of AUC(0-inf) determined by extrapolation. It was calulating using formula: Area under the plasma activity versus time profile from given measurable time to infinity (AUCt-inf)/Area under the plasma activity versus time profile from time zero to infinity (AUC0-inf).
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Extrapolated Area Under the Curve (AUC Percent [%] Extrap
Week 0
|
2.847 Percentage of AUC
Geometric Coefficient of Variation 47.917
|
3.392 Percentage of AUC
Geometric Coefficient of Variation 63.420
|
|
Extrapolated Area Under the Curve (AUC Percent [%] Extrap
Week 28
|
2.143 Percentage of AUC
Geometric Coefficient of Variation 17.743
|
3.424 Percentage of AUC
Geometric Coefficient of Variation 65.849
|
SECONDARY outcome
Timeframe: 0-96 hours post-injection on Week 0 and Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = Number of participants with available data for specific timepoints.
Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC \[0-inf\]) divided by AUC (0-inf). (AUMC \[0-inf\]) is the area under the first moment plasma concentration-time curve from time 0 to infinity.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Mean Residence Time
Week 0
|
27.101 hour
Geometric Coefficient of Variation 13.400
|
27.941 hour
Geometric Coefficient of Variation 21.114
|
|
Mean Residence Time
Week 28
|
24.070 hour
Geometric Coefficient of Variation 4.347
|
27.739 hour
Geometric Coefficient of Variation 22.177
|
SECONDARY outcome
Timeframe: 0-96 hours post-injection on Week 0 and Week 28Population: The PK analysis set included sub-set of participants from FAS who were included for PK assessments. Number analyzed = Number of participants with available data for specific timepoints.
The terminal elimination rate constant was estimated using linear regression on the terminal part of the log(activity) versus time profile.
Outcome measures
| Measure |
Adolescents (12-17 Years)
n=4 Participants
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=11 Participants
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Terminal Elimination Rate Constant (λz)
Week 0
|
0.036 1/hour
Geometric Coefficient of Variation 13.526
|
0.034 1/hour
Geometric Coefficient of Variation 18.083
|
|
Terminal Elimination Rate Constant (λz)
Week 28
|
0.039 1/hour
Geometric Coefficient of Variation 5.749
|
0.034 1/hour
Geometric Coefficient of Variation 16.862
|
Adverse Events
Adolescents (12-17 Years)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Adults (18-70 Years)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adolescents (12-17 Years)
n=13 participants at risk
Participants with haemophilia A aged 12-17 years with greater than or equal to (≥) 150 exposure days to other FVIII product received one single bolus dose of 50 international unit per Kilogram (IU/kg) of turoctocog alfa pegol (N8-GP), administered intravenously (IV) every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
Adults (18-70 Years)
n=23 participants at risk
Participants with haemophilia A aged 18-70 years with ≥150 exposure days to other FVIII product received one single bolus dose of 50 IU/kg of turoctocog alfa pegol (N8-GP), administered IV every 4th day (96 hours) or twice weekly (investigator's discretion). All bleeds were to be treated with doses between 20-75 IU/kg according to the severity and location of the bleeding episode.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.7%
1/13 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/13 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
8.7%
2/23 • Number of events 2 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Infections and infestations
Influenza
|
7.7%
1/13 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
1/13 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
7.7%
1/13 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Injury, poisoning and procedural complications
Medication error
|
7.7%
1/13 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.7%
1/13 • Number of events 2 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
General disorders
Pyrexia
|
15.4%
2/13 • Number of events 2 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 2 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
4.3%
1/23 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
0.00%
0/23 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
|
Investigations
Weight decreased
|
7.7%
1/13 • Number of events 1 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
8.7%
2/23 • Number of events 3 • From start of treatment (Week 0) until end of trial (Week 32)
All presented AEs are treatment-emergent adverse events. A TEAEs was defined as an event with onset after first N8-GP administration. Results were based on the SAS which included all participants exposed to N8-GP in this trial.
|
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