A Phase 3 interventional study of turoctocog alfa pegol (N8-GP) in Haemophilia A, sponsored by Novo Nordisk A/S. Completed at 11 sites in China. Open to male participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
The study investigates how well the medicine called turoctocog alfa pegol (N8-GP) works in previously treated Chinese patients with severe haemophilia A.
Participants will be treated with N8-GP. This is a medicine that doctors can already prescribe in other countries.
The medicine will be injected into a vein (intravenous injections) and blood samples will be collected.
The study will last for about 7-8 months. Participants will have between 8 and 15 visits to the clinic and possibly a number of phone calls with the study doctor.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 36 is above the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will receive prophylaxis with 50 IU/kg N8-GP every 4 days for a treatment period of at least 28 weeks (with the possibility of switching to twice-weekly dosing during the treatment period at the discretion of the investigator).
Drug: turoctocog alfa pegol (N8-GP)
N8-GP will be injected into a vein (intravenous injections) every 4 days in at least 28 weeks
Number of Bleeding Episodes Per Year (Annualised Bleeding Rate)
Number of bleeding episodes per year (Annualised Bleeding Rate) data is reported. Annualised bleeding rate (ABR) is the number of bleeding episodes per year.
Time frame: From start of treatment (Week 0) until Week 28
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)
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.
Time frame: From start of treatment (Week 0) until Week 28
Number of Injections Needed to Treat Bleeding Episodes
The mean number of injections of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.
Time frame: From start of treatment (Week 0) until Week 28
Consumption of N8-GP for Prophylaxis
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).
Time frame: From start of treatment (Week 0) until Week 28
FVIII Trough Activity During Prophylaxis
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.
Time frame: From start of treatment (Week 0) (excluding the first exposure) until Week 28
Percentage of Participants With Incidence Rate of Confirmed FVIII Inhibitors ≥0.6 BU
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.
Time frame: From start of treatment (Week 0) until Week 28
Number of Adverse Events (AEs)
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.
Time frame: From start of treatment (Week 0) until end of trial (Week 32)
Number of Serious Adverse Events (SAEs)
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).
Time frame: From start of treatment (Week 0) until end of trial (Week 32)
Incremental Recovery (IR)
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.
Time frame: 30 min post-injection at Week 0, Week 28
FVIII Activity 30 Min Post-injection (C30min)
FVIII plasma activity was measured after 30 mins of injection. FVIII activity was measured with a chromogenic assay.
Time frame: 30 min post-injection at Week 0, Week 28
FVIII Trough Activity 96 h Post-injection (C96h)
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.
Time frame: Single-dose: 96 h ± 8 h post-injection at Week 0, Steady-state: 96 h ± 8 h post-injection at Week 28
Area Under the Curve (AUC0-inf)
Area under the plasma activity versus time profile from time zero to infinity (AUC0-inf) was measured.
Time frame: 0-96 hours post-injection at Week 0 and Week 28
Area Under the Curve (0-t)
Area under the plasma activity versus time profile from time zero to last measurable activity (AUC0-t) was measured.
Time frame: 0-96 hours post-injection at Week 0 and Week 28
Area Under the Curve (0-96h)
Area under the plasma activity versus time profile from time zero to 96 hours (AUC0-96h) was measured.
Time frame: 0-96 hours post-injection at Week 0 and Week 28
Accumulation Ratio
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.
Time frame: 0-96 hours post-injection on Week 28
Terminal Half-life (t½)
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.
Time frame: 0-96 hours post-injection on Week 0 and Week 28
Clearance (CL)
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.
Time frame: Single-dose: 0-96 h post-injection at Week 0, Steady-state: 0-96 h post-injection at Week 28
Apparent Volume of Distribution (Vz) Based on the Terminal Phase
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).
Time frame: 0-96 hours post-injection on Week 0 and Week 28
Apparent Volume of Distribution (Vss) Based on Steady-state
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).
Time frame: 0-96 h post-injection at Week 28
Extrapolated Area Under the Curve (AUC Percent [%] Extrap
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).
Time frame: 0-96 hours post-injection on Week 0 and Week 28
Mean Residence Time
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.
Time frame: 0-96 hours post-injection on Week 0 and Week 28
Terminal Elimination Rate Constant (λz)
The terminal elimination rate constant was estimated using linear regression on the terminal part of the log(activity) versus time profile.
Time frame: 0-96 hours post-injection on Week 0 and Week 28
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.
| Milestone | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Started | 13 | 23 |
| Full analysis set | 13 | 23 |
| Safety analysis set | 13 | 23 |
| Pharmacokinetic (pk) analysis set | 4 | 11 |
| Completed | 13 | 23 |
| Not completed | 0 | 0 |
Number of bleeding episodes per year (Annualised Bleeding Rate) data is reported. Annualised bleeding rate (ABR) is the number of bleeding episodes per year.
| Bleeding episodes per year | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Number of Bleeding Episodes Per Year (Annualised Bleeding Rate) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 1.83) |
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.
| Bleeding Episodes | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Excellent | 18 | 22 |
| Good | 3 | 6 |
| Moderate | 3 | 0 |
| None | 0 | 0 |
| Missing | 0 | 0 |
The mean number of injections of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.
| Injections per bleed | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Number of Injections Needed to Treat Bleeding Episodes | 2 ± 0.8 | 1 ± 0.3 |
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).
| IU/kg/year | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Consumption of N8-GP for Prophylaxis | 4909.5 ± 252.0 | 4873.9 ± 237.6 |
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.
| International unit per milliliter(IU/mL) | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| FVIII Trough Activity During Prophylaxis | 0.032 (0.023 to 0.044) | 0.034 (0.025 to 0.045) |
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.
| Percentage of participants | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Percentage of Participants With Incidence Rate of Confirmed FVIII Inhibitors ≥0.6 BU | 0.00 | 0.00 |
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.
| Events | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Number of Adverse Events (AEs) | 15 | 25 |
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).
| Events | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Number of Serious Adverse Events (SAEs) | 0 | 0 |
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.
| (IU/mL)/(IU/kg) | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 0.023 ± 28.107 | 0.023 ± 28.367 |
| Week 28 | 0.029 ± 1.443 | 0.024 ± 23.535 |
FVIII plasma activity was measured after 30 mins of injection. FVIII activity was measured with a chromogenic assay.
| IU/mL | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 1.178 ± 24.531 | 1.196 ± 27.304 |
| Week 28 | 1.557 ± 0.646 | 1.302 ± 21.521 |
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.
| IU/mL | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 0.033 ± 36.048 | 0.039 ± 44.608 |
| Week 28 | 0.032 ± 14.616 | 0.045 ± 58.020 |
Area under the plasma activity versus time profile from time zero to infinity (AUC0-inf) was measured.
| h*(IU/mL) | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 31.556 ± 20.100 | 33.650 ± 26.123 |
| Week 28 | 37.274 ± 4.541 | 37.952 ± 28.030 |
Area under the plasma activity versus time profile from time zero to last measurable activity (AUC0-t) was measured.
| h*(IU/mL) | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 30.578 ± 19.999 | 32.300 ± 26.565 |
| Week 28 | 36.467 ± 4.292 | 36.406 ± 27.173 |
Area under the plasma activity versus time profile from time zero to 96 hours (AUC0-96h) was measured.
| h*(IU/mL) | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 30.509 ± 19.989 | 32.269 ± 26.558 |
| Week 28 | 36.428 ± 4.251 | 36.398 ± 27.168 |
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.
| Ratio of AUC | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Accumulation Ratio | 1.152 ± 19.682 | 1.086 ± 53.085 |
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.
| hour (h) | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 19.106 ± 14.019 | 20.200 ± 20.422 |
| Week 28 | 17.729 ± 5.568 | 20.238 ± 18.882 |
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.
| milliter per hour per kilogram (mL/h/kg) | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 1.636 ± 17.092 | 1.550 ± 29.123 |
| Week 28 | 1.434 ± 4.488 | 1.434 ± 25.335 |
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).
| milliter per kilogram (mL/kg) | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 45.098 ± 24.375 | 45.165 ± 34.649 |
| Week 28 | 36.673 ± 4.042 | 41.878 ± 27.534 |
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).
| milliter per kilogram (mL/kg) | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Apparent Volume of Distribution (Vss) Based on Steady-state | 34.511 ± 5.727 | 39.786 ± 28.558 |
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).
| Percentage of AUC | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 2.847 ± 47.917 | 3.392 ± 63.420 |
| Week 28 | 2.143 ± 17.743 | 3.424 ± 65.849 |
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.
| hour | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 27.101 ± 13.400 | 27.941 ± 21.114 |
| Week 28 | 24.070 ± 4.347 | 27.739 ± 22.177 |
The terminal elimination rate constant was estimated using linear regression on the terminal part of the log(activity) versus time profile.
| 1/hour | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| Week 0 | 0.036 ± 13.526 | 0.034 ± 18.083 |
| Week 28 | 0.039 ± 5.749 | 0.034 ± 16.862 |
Collected over From start of treatment (Week 0) until end of trial (Week 32). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adolescents (12-17 Years) | 0/13 (0%) | 0/13 (0%) | 7/13 (53.8%) |
| Adults (18-70 Years) | 0/23 (0%) | 0/23 (0%) | 4/23 (17.4%) |
| Event | Adolescents (12-17 Years) | Adults (18-70 Years) |
|---|---|---|
| PyrexiaGeneral disorders | 2/13 | 0/23 |
| HyperuricaemiaMetabolism and nutrition disorders | 0/13 | 2/23 |
| Weight decreasedInvestigations | 1/13 | 2/23 |
| Abdominal discomfortGastrointestinal disorders | 1/13 | 0/23 |
| DizzinessNervous system disorders | 1/13 | 0/23 |
| InfluenzaInfections and infestations | 1/13 | 0/23 |
| LeukopeniaBlood and lymphatic system disorders | 1/13 | 0/23 |
| Ligament sprainInjury, poisoning and procedural complications | 1/13 | 0/23 |
| Medication errorInjury, poisoning and procedural complications | 1/13 | 0/23 |
| NauseaGastrointestinal disorders | 1/13 | 0/23 |
Results were based on the full analysis set (FAS) which included all participants exposed to N8-GP in this trial.
| Age, Continuous(Years) | Adolescents (12-17 Years) | Adults (18-70 Years) | Total |
|---|---|---|---|
| Mean | 13.7 ± 1.7 | 28.7 ± 9.2 | 23.3 ± 10.4 |
| Sex: Female, Male(Participants) | Adolescents (12-17 Years) | Adults (18-70 Years) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 13 | 23 | 36 |
| Ethnicity (NIH/OMB)(Participants) | Adolescents (12-17 Years) | Adults (18-70 Years) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 13 | 23 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Adolescents (12-17 Years) | Adults (18-70 Years) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 13 | 23 | 36 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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