Comparison · NCT04085601-2fe85589
Pegcetacoplan vs Standard of Care: Number of Subjects With an Hb Response in the Absence of Transfusions
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. Pegcetacoplan vs Standard of Care: Number of Subjects With an Hb Response in the Absence of Transfusions. Trial comparisons, record NCT04085601-2fe85589. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04085601-2fe85589
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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 | 0.714 | 0.549 | 0.837 | wilson | |
| Risk in group 2 | 0.0556 | 0.00988 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | 0.659 | 0.398 | 0.789 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 12.9 | 1.89 | 87.4 | log | |
| Odds ratio, group 1 over group 2 | 42.5 | 4.97 | 363 | log | |
| Number needed to treat, for one more participant with the outcome on Pegcetacoplan than on Standard of Care | 1.52 | 1.27 | 2.51 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pegcetacoplan | Subjects were received SC infusion of pegcetacoplan 1080 mg twice weekly or every 3 days up to end of the RCP (Week 26). Subjects were not allowed to receive treatment with other complement inhibitors. | 25 | 35 | OG000 |
| Group 2 | Standard of Care | Subjects continued to receive SoC treatment but were not allowed to receive treatment with a complement inhibitor unless they qualified for pegcetacoplan escape therapy. | 1 | 18 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With an Hb Response in the Absence of Transfusions
- Description
- An Hb response was defined as a =\>1 g/dL increase in Hb from baseline at Week 26.
- Time frame
- Baseline and Week 26
- Population
- The ITT set included all subjects assigned to treatment.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH
- NCT number
- NCT04085601
- Phases
- PHASE3
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Interventions
- APL-2
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Results first posted
- 2022-10-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04085601?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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