Comparison · NCT02141074-e61f58ee
Pre-prophylaxis vs Prophylaxis: Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Pre-prophylaxis vs Prophylaxis: Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days). Trial comparisons, record NCT02141074-e61f58ee. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02141074-e61f58ee
On this page
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 | 0.0588 | 0.0163 | 0.191 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000139 | 0.121 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0588 | -0.0691 | 0.191 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Pre-prophylaxis than on Prophylaxis | 17 | 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 | Participants received nonacog beta pegol 40 international units/kilogram (IU/kg) intravenous injection at intervals longer than a week on-demand for bleeding episodes until they were 24 months of age or until 20 exposure days (ED), whichever came first, in the main phase. Participants switched from pre-prophylaxis treatment to prophylaxis treatment no later than 24 months of age/20 ED, whichever came first. | 2 | 34 | OG000 |
| Group 2 | Prophylaxis | Participants who started with pre-prophylaxis were switched to prophylaxis no later than 24 months of age or upon reaching 20EDs, whichever came first. These participants that switched from pre-prophylaxis and other participants who started directly on prophylaxis since visit 1 received once weekly dosing of nonacog beta pegol 40 IU/kg intravenous injection in the main phase, extension phase, and until the end of treatment. | 0 | 28 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) (50 Exposure Days)
- Description
Number of participants with incidence of inihibitory antibodies against FIX after 50 ED is presented and defined as an inhibitory antibody titre greater than equal to 0.6 Bethesda unit (BU) at two consecutive tests performed at the central laboratory and also tested positive for nonacog beta pegol binding antibodies.
- Time frame
- When minimum 20 previously untreated patients (PUPs) have reached at least 50 exposure days (ED) (up to 156 weeks)
- Population
- Safety analysis set included all participants exposed to nonacog beta pegol. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
- NCT number
- NCT02141074
- Phases
- PHASE3
- Conditions
- Congenital Bleeding Disorder, Haemophilia B
- Interventions
- nonacog beta pegol
- Lead sponsor
- Novo Nordisk A/S
- Results first posted
- 2023-12-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02141074?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02141074-e61f58ee