Comparison · NCT04743804-ac5cf4ca
Ravulizumab vs Placebo: Number of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26
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. Ravulizumab vs Placebo: Number of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26. Trial comparisons, record NCT04743804-ac5cf4ca. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04743804-ac5cf4ca
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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 | 0.222 | 0.0632 | 0.547 | wilson | |
| Risk in group 2 | 0.429 | 0.158 | 0.75 | wilson | |
| Risk difference, group 1 minus group 2 | -0.206 | -0.565 | 0.217 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.519 | 0.117 | 2.3 | log | |
| Odds ratio, group 1 over group 2 | 0.381 | 0.0435 | 3.34 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ravulizumab than on Placebo | 4.85 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ravulizumab | Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Treatment Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. | 2 | 9 | OG000 |
| Group 2 | Placebo | Participants received weight-based dosages of placebo matched to ravulizumab for 26 weeks during the Initial Treatment Period. Participants received a loading dose of placebo matched to ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. | 3 | 7 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26
- Description
TMA response required the following: 1) Normalization of platelet count without transfusion support during the prior 7 days. 2) Normalization of LDH. 3) Improvement in glomerular filtration rate (eGFR) of \>= 30% compared to baseline. Participants must meet each TMA criterion at 2 separate assessments obtained at least 24 hours apart, and any measurement in between.
- Time frame
- Week 26
- Population
The Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization.
Source ClinicalTrials.gov
Trial
- Title
- Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger
- NCT number
- NCT04743804
- Phases
- PHASE3
- Conditions
- Thrombotic Microangiopathy
- Interventions
- Ravulizumab, Placebo, Best Supportive Care
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2023-12-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04743804?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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