Comparison · NCT03393975-337b3a25
Prophylaxis Cohort I: TAK-755 Then SoC vs Prophylaxis Cohort II: SoC Then TAK-755: Number of Participants With Neutralizing Antibodies to ADAMTS13 During Prophylactic Treatment
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. Prophylaxis Cohort I: TAK-755 Then SoC vs Prophylaxis Cohort II: SoC Then TAK-755: Number of Participants With Neutralizing Antibodies to ADAMTS13 During Prophylactic Treatment. Trial comparisons, record NCT03393975-337b3a25. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03393975-337b3a25
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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 | 0 | 0.155 | wilson | |
| Risk in group 2 | 0.037 | 0.00657 | 0.183 | wilson | |
| Risk difference, group 1 minus group 2 | -0.037 | -0.183 | 0.121 | 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 fewer participant with the outcome on Prophylaxis Cohort I: TAK-755 Then SoC than on Prophylaxis Cohort II: SoC Then TAK-755 | 27 | 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 | Prophylaxis Cohort I: TAK-755 Then SoC | Participants received a single IV infusion of 40 IU/kg TAK-755 ORT Q2W for 6 months in Period 1 followed by SoC for 6 months in Period 2. Thereafter participants received TAK-755 SIN dose IV infusion of 40 IU/kg Q2W for 6 months in Period 3. TAK-755 ORT could be replaced with TAK-755 SIN and vice versa depending on availability and other criteria. | 0 | 21 | OG000 |
| Group 2 | Prophylaxis Cohort II: SoC Then TAK-755 | Participants received SoC for 6 months in Period 1 followed by IV infusions of 40 IU/kg dose of TAK-755 ORT Q2W in Period 2 for the next 6 months. Thereafter participants received TAK-755 SIN dose IV infusions of 40 IU/kg Q2W for another 6 months in Period 3. TAK-755 ORT could be replaced with TAK-755 SIN and vice versa depending on availability and other criteria. | 1 | 27 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Neutralizing Antibodies to ADAMTS13 During Prophylactic Treatment
- Description
Neutralizing antibodies were measured by a Bethesda method with Nijmegen modification using the ADAMTS13 FRETS-VWF73 activity assay. As per planned analysis, data for this outcome measure were collected and reported per sequence (Prophylaxis Cohort I: TAK-755 Then SoC and Prophylaxis Cohort II: SoC Then TAK-755) for the prophylaxis cohorts only.
- Time frame
- Up to 79.6 months
- Population
The Safety Analysis Set included all participants treated with at least 1 dose of TAK-755 or SoC treatment after randomization. 2 participants randomized to Prophylaxis Cohort I received actual treatment as per Prophylaxis Cohort II and are presented per actual treatment arm.
Source ClinicalTrials.gov
Trial
- Title
- A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP)
- NCT number
- NCT03393975
- Phases
- PHASE3
- Conditions
- Thrombotic Thrombocytopenic Purpura (TTP)
- Interventions
- TAK-755, Standard of care
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2025-03-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03393975?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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