Comparison · NCT05096403-5e1cbcb5
Pegcetacoplan Double Blind During Part A vs Placebo Matching Pegcetacoplan-Double-blind During Part A: Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for Indirect Bilirubin Levels-Part A
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. Pegcetacoplan Double Blind During Part A vs Placebo Matching Pegcetacoplan-Double-blind During Part A: Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for Indirect Bilirubin Levels-Part A. Trial comparisons, record NCT05096403-5e1cbcb5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05096403-5e1cbcb5
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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 | 0.846 | 0.578 | 0.957 | wilson | |
| Risk in group 2 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk difference, group 1 minus group 2 | 0.679 | 0.2 | 0.855 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 5.08 | 0.836 | 30.8 | log | |
| Odds ratio, group 1 over group 2 | 27.5 | 2 | 379 | log | |
| Number needed to treat, for one more participant with the outcome on Pegcetacoplan Double Blind During Part A than on Placebo Matching Pegcetacoplan-Double-blind During Part A | 1.47 | 1.17 | 4.99 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | 11 | 13 | OG000 |
| Group 2 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection | 1 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for Indirect Bilirubin Levels-Part A
- Description
- Percentage of patients with Indirect Bilirubin level normalization during the initial 24 weeks of the study
- Time frame
- Week 24
- Population
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
- NCT number
- NCT05096403
- Phases
- PHASE3
- Conditions
- Cold Agglutinin Disease
- Interventions
- Pegcetacoplan, Placebo matching Pegcetacoplan
- Lead sponsor
- Swedish Orphan Biovitrum
- Results first posted
- 2025-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05096403?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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