Comparison · NCT02137850-0be2d2c6
Pre-prophylaxis vs Prophylaxis: Number of Participants With Confirmed High Titre Inhibitors (Defined as Inhibitor Titre Above 5 Bethesda Units (BU)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Pre-prophylaxis vs Prophylaxis: Number of Participants With Confirmed High Titre Inhibitors (Defined as Inhibitor Titre Above 5 Bethesda Units (BU). Trial comparisons, record NCT02137850-0be2d2c6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02137850-0be2d2c6
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0545 | 0.0187 | 0.149 | wilson | |
| Risk in group 2 | 0.118 | 0.0608 | 0.215 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0631 | -0.167 | 0.0467 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.464 | 0.129 | 1.66 | log | |
| Odds ratio, group 1 over group 2 | 0.433 | 0.109 | 1.72 | log | |
| Number needed to treat, for one fewer participant with the outcome on Pre-prophylaxis than on Prophylaxis | 15.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pre-prophylaxis | At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment. | 3 | 55 | OG000 |
| Group 2 | Prophylaxis | For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment. | 8 | 68 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Confirmed High Titre Inhibitors (Defined as Inhibitor Titre Above 5 Bethesda Units (BU)
- Description
- Number of participants with confirmed high titre inhibitors (defined as inhibitor titre above 5 Bethesda Units (BU) was reported during the main and extension phase of the trial.
- Time frame
- From start of the treatment up to 8.9 years
- Population
Results were based on safety analysis set (SAS). The SAS consist of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
- NCT number
- NCT02137850
- Phases
- PHASE3
- Conditions
- Congenital Bleeding Disorder, Haemophilia A
- Interventions
- turoctocog alfa pegol
- Lead sponsor
- Novo Nordisk A/S
- Results first posted
- 2024-10-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02137850?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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