Trial · NCT04956276
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion Of Participants Achieving A ≥ 2 Grams/Deciliter (g/dL) Increase In Hemoglobin (Hgb) From Baseline To The End Of Primary Treatment | Baseline through Week 12 | Participants will have to achieve this increase without requiring any increase in the dose of an existing WAIHA medication after Day 1 (baseline) and without packed red blood cells (pRBC) transfusions after Day 14. |
| Secondary | Total Number Of Units Of pRBCs Transfused | Baseline through Week 12 | |
| Secondary | Number Of Hgb Measurements ≥ 2 g/dL From Baseline To The End Of Primary Treatment | Baseline, Week 12 | |
| Secondary | Time To Hgb Increase By ≥ 2 g/dL From Baseline | Baseline through Week 12 | |
| Secondary | Proportion Of Participants Who Require New WAIHA Rescue Medication Or Any Increase In The Dose Of An Existing WAIHA Medication Or pRBC Transfusions For The Treatment Of Anemia | Day 15 through Week 12 | |
| Secondary | Proportion Of Participants Achieving A ≥ 2 g/dL Increase In Hgb From Baseline Through Week 4 | Baseline through Week 4 | Participants need to achieve this increase without requiring any increase in the dose of an existing WAIHA medication after Day 1 and without pRBC transfusions after Day 14. |
| Secondary | Change From Baseline To The End Of Primary Treatment In Serum Lactate Dehydrogenase (LDH) Levels | Baseline, Week 12 | |
| Secondary | Change From Baseline To The End Of Primary Treatment In Absolute Reticulocyte Count | Baseline, Week 12 | |
| Secondary | Change From Baseline To The End Of Primary Treatment In Serum Indirect Bilirubin | Baseline, Week 12 | |
| Secondary | Change From Baseline To The End Of Primary Treatment In Serum Haptoglobin | Baseline, Week 12 | |
| Secondary | Total Corticosteroid Usage From Baseline To The End Of Primary Treatment | Baseline, Week 12 | |
| Secondary | Proportion Of Participants Who Require Any Increase In Corticosteroid Dose From Baseline To The End Of Follow Up After Primary Treatment | Baseline through Week 20 | |
| Secondary | Change In Corticosteroid Dose From The End Of Primary Treatment To The End Of Follow Up | Week 12, Week 20 | |
| Secondary | Number Of Days To Beginning Of Corticosteroid Taper During Follow Up After Primary Treatment | Baseline through Week 20 | Taper is defined as the first day that a lower dose of corticosteroids is prescribed/taken. |
| Secondary | Number Of Days To Corticosteroid Maintenance Dose During Follow Up After Primary Treatment | Baseline through Week 20 | Maintenance dose will be defined as \< 10 milligrams (mg)/day of prednisone or equivalent. |
| Secondary | Number Of Days To Reach Corticosteroid Discontinuation From The End Of Primary Treatment To The End Of Follow Up After Primary Treatment | Week 12 through Week 20 | |
| Secondary | Incidence And Titers Of Anti-drug Antibodies Against ALXN1830 Over Time | Up to 2 years | |
| Secondary | Incidence And Titers Of Neutralizing Antibodies Against ALXN1830 Over Time | Up to 2 years | |
| Secondary | Serum Trough Concentrations Of ALXN1830 Over Time | Up to 2 years | |
| Secondary | Change In Serum Total Immunoglobulin G (IgG) Levels By Dose Group And Time Point | Up to 2 years |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04956276/registered