Trial · NCT04434092
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Transfusion Avoidance (TA) | Baseline to Week 25 | Primary Analysis Population (PAP) included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid lactate dehydrogenase (LDH) level assessment by the central laboratory after the first IV infusion by planned treatment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Hemolysis Control Measured by LDH | Week 5 to Week 25 | PAP included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid LDH level assessment by the central laboratory after the first IV infusion by planned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Breakthrough Hemolysis (BTH) | Baseline to Week 25 | PAP included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid LDH level assessment by the central laboratory after the first IV infusion by planned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Stabilization of Hemoglobin | Baseline to Week 25 | PAP included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid LDH level assessment by the central laboratory after the first IV infusion by planned treatment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fatigue Assessed by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale | Baseline to Week 25 | PAP included all randomized participants in Arms A and B who received at least one dose of the originally assigned treatment and having at least one valid LDH level assessment by the central laboratory after the first IV infusion by planned treatment. Overall number of participants analyzed is the number of participants ≥18 years with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints. | score on scale | MEAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Up to 6 years | |||
| SECONDARY | Percentage of Participants With Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity and Infections (Including Meningococcal Meningitis) | Up to 6 years | |||
| SECONDARY | Percentage of Participants With AEs Leading to Study Drug Discontinuation | Up to 6 years | |||
| SECONDARY | Percentage of Participants With Clinical Manifestations of Drug-Target-Drug Complex (DTDC) Formation Amongst Participants Who Switched to Crovalimab Treatment From Eculizumab Treatment | Up to 6 years | |||
| SECONDARY | Serum Concentrations of Crovalimab And Eculizumab Over Time | Up to 6 years | |||
| SECONDARY | Percentage of Participants With Anti-Crovalimab Antibodies | Up to 6 years | |||
| SECONDARY | Change in Pharmacodynamic (PD) Biomarkers Including Complement Activity (CH50) Over Time | Up to 6 years | |||
| SECONDARY | Change Over Time in Free C5 Concentration in Crovalimab-Treated Participants | Up to 6 years | |||
| SECONDARY | Observed Value in Reticulocyte Count (Count/Milliliters [mL]) | Up to 6 years | |||
| SECONDARY | Observed Value in Haptoglobin (Milligrams Per Deciliter [mg/dL]) | Up to 6 years | |||
| SECONDARY | Change From Baseline in Absolute Reticulocyte Count | Baseline, Day 1 Week 1, Week 2, 3, 4, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 and 25 | Randomized Safety Population includes all randomized participants who have received at least one dose of study treatment. Includes only participants from Arms A and B. Overall number of participants analyzed is the number of participants ≥18 years with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints. | 10^9 cells/liter (L) | MEAN |
| SECONDARY | Change From Baseline in Free Hemoglobin | Baseline, Week 2, 3, 4, 5, 9, 13, 17, 21, and 25 | Randomized Safety Population includes all randomized participants who have received at least one dose of study treatment. Includes only participants from Arms A and B. Overall number of participants analyzed is the number of participants ≥18 years with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints. | milligram per litre (mg)/L | MEAN |
| SECONDARY | Change From Baseline in Haptoglobin | Baseline, Week 2, 3, 4, 5, 9, 13, 15, 17, 21, and 25 | Randomized Safety Population includes all randomized participants who have received at least one dose of study treatment. Includes only participants from Arms A and B. Overall number of participants analyzed is the number of participants ≥18 years with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints. | gram (g)/L | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04434092/outcomes