Trial · NCT01480180
Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
NCT01480180, Phase 3, Completed, Novo Nordisk A/S; results first posted 2020-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A. Trials, record NCT01480180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01480180
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
- NCT number
- NCT01480180
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 186 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Interventions
- turoctocog alfa pegol
- First posted
- 2011-11-28
- Last updated
- 2020-11-23
- Other registries' IDs
- eudract:2011-001142-15
- Results first posted
- 2020-04-20
Source ClinicalTrials.gov
Registered outcomes75
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 19 Months | After approximately 19 months | All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors. |
| Primary | Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 19 Months | After approximately 19 months | Annualised bleeding rate (ABR) is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP. |
| Primary | The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 25 Months | After approximately 25 months | All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors. |
| Primary | Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 25 Months | After approximately 25 months | ABR is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP. |
| Primary | Incidence Rate of FVIII-inhibitors ≥0.6 BU: At Approximately 80 Months | At approximately 80 months | All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors. |
| Primary | Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 80 Months | After approximately 80 months | Annualised bleeding rate (ABR) is the number of bleeding episodes per year reported during the prophylactic treatment with N8-GP. |
| Secondary | Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months | After approximately 19 months | 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. |
| Secondary | Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months | After approximately 25 months | 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. |
| Secondary | Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months | After approximately 80 months | 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. |
| Secondary | Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 19 Months | After approximately 19 months | The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported. |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 registered outcomesOutcomes75
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 19 Months | After approximately 19 months | Results are based on the safety analysis set (SAS). SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm. | Inhibitor rate | NUMBER |
| PRIMARY | Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 19 Months | After approximately 19 months | Results were based on the full analysis set (FAS) which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm. | Bleeds per participant per year | MEDIAN |
| PRIMARY | The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 25 Months | After approximately 25 months | Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm. | Inhibitor rate | NUMBER |
| PRIMARY | Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 25 Months | After approximately 25 months | Results are based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm. | Bleeds per participant per year | MEDIAN |
| PRIMARY | Incidence Rate of FVIII-inhibitors ≥0.6 BU: At Approximately 80 Months | At approximately 80 months | Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm. | Inhibitor rate | NUMBER |
| PRIMARY | Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 80 Months | After approximately 80 months | Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm. | Bleeds per participant per year | MEDIAN |
| SECONDARY | Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months | After approximately 19 months | Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed. | Bleeding episodes | COUNT_OF_UNITS |
| SECONDARY | Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months | After approximately 25 months | Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed. | Bleeding episodes | COUNT_OF_UNITS |
| SECONDARY | Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months | After approximately 80 months | Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed. | Bleeding episodes | COUNT_OF_UNITS |
| SECONDARY | Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 19 Months | After approximately 19 months | Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions in respective arm. | Number of infusions | MEAN |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 outcomesResults by group431
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 19 Months | N8-GP 50 U/kg Prophylaxis Q4D | 0.006 | Inhibitor rate | ||
| The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 19 Months | N8-GP 20-75 U/kg On-demand | 0 | Inhibitor rate | ||
| Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 19 Months | N8-GP Prophylaxis | 1.33 | Inter-Quartile Range 0 to 4.61 | Bleeds per participant per year | |
| The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 25 Months | N8-GP 50 U/kg Prophylaxis Q4D | 0.006 | Inhibitor rate | ||
| The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 25 Months | N8-GP 75 U/kg Prophylaxis Q7D | 0 | Inhibitor rate | ||
| The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 25 Months | N8-GP 20-75 U/kg On-demand | 0 | Inhibitor rate | ||
| Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 25 Months | N8-GP 50 U/kg Prophylaxis Q4D | 1.36 | Inter-Quartile Range 0.00 to 4.00 | Bleeds per participant per year | |
| Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 25 Months | N8-GP 75 U/kg Prophylaxis Q7D | 0 | Inter-Quartile Range 0.00 to 2.36 | Bleeds per participant per year | |
| Incidence Rate of FVIII-inhibitors ≥0.6 BU: At Approximately 80 Months | N8-GP Prophylaxis | 0.006 | Inhibitor rate | ||
| Incidence Rate of FVIII-inhibitors ≥0.6 BU: At Approximately 80 Months | N8-GP 20-75 U/kg On-demand | 0 | Inhibitor rate |
1 to 10 of 431Source ClinicalTrials.gov
See all 431 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Phase | STARTED | Prophylaxis | 174 | |
| Main Phase | STARTED | On-demand | 12 | |
| Main Phase | STARTED | N8-GP 50 U/kg Prophylaxis Q4D | 0 | |
| Main Phase | STARTED | N8-GP 75 U/kg Prophylaxis Q7D | 0 | |
| Main Phase | STARTED | N8-GP 20-75 U/kg On-demand | 0 | |
| Main Phase | STARTED | N8-GP Prophylaxis | 0 | |
| Main Phase | Max. Participants After Switching | Prophylaxis | 175 | |
| Main Phase | Max. Participants After Switching | On-demand | 11 | |
| Main Phase | Max. Participants After Switching | N8-GP 50 U/kg Prophylaxis Q4D | 0 | |
| Main Phase | Max. Participants After Switching | N8-GP 75 U/kg Prophylaxis Q7D | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events423
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | N8-GP 50 U/kg Q4D Prophylaxis | 4 | 177 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | N8-GP 75 U/kg Q7D Prophylaxis | 1 | 61 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | N8-GP 20-75 U/kg On-demand | 1 | 12 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | N8-GP 50 U/kg Q4D Prophylaxis | 9 | 177 | 12 |
| other | Abdominal pain upper | Gastrointestinal disorders | N8-GP 75 U/kg Q7D Prophylaxis | 3 | 61 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | N8-GP 20-75 U/kg On-demand | 0 | 12 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | N8-GP 50 U/kg Q4D Prophylaxis | 3 | 177 | 4 |
| other | Acne | Skin and subcutaneous tissue disorders | N8-GP 75 U/kg Q7D Prophylaxis | 4 | 61 | 4 |
| other | Acne | Skin and subcutaneous tissue disorders | N8-GP 20-75 U/kg On-demand | 0 | 12 | 0 |
| other | Alanine aminotransferase increased | Investigations | N8-GP 50 U/kg Q4D Prophylaxis | 12 | 177 | 17 |
1 to 10 of 423Source ClinicalTrials.gov
See all 423 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N8-GP 50 U/kg Q4D Prophylaxis | 1 | 177 |
| Total, all-cause mortality | N8-GP 75 U/kg Q7D Prophylaxis | 0 | 61 |
| Total, all-cause mortality | N8-GP 20-75 U/kg On-demand | 0 | 12 |
| Total, other adverse events | N8-GP 50 U/kg Q4D Prophylaxis | 144 | 177 |
| Total, other adverse events | N8-GP 75 U/kg Q7D Prophylaxis | 50 | 61 |
| Total, other adverse events | N8-GP 20-75 U/kg On-demand | 10 | 12 |
| Total, serious adverse events | N8-GP 50 U/kg Q4D Prophylaxis | 24 | 177 |
| Total, serious adverse events | N8-GP 75 U/kg Q7D Prophylaxis | 7 | 61 |
| Total, serious adverse events | N8-GP 20-75 U/kg On-demand | 3 | 12 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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