Trial · NCT04654468
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percentage of Participants With Hemolysis Control | From Week 5 up to Week 25 | A Generalized Estimating Equation (GEE) was used to estimate the population-average percentage of the participants with hemolysis control (measured by lactate dehydrogenase (LDH) ≤1.5 x upper limit of normal (ULN)) from Week 5 to Week 25 taking account of the intra-patient and inter-patient correlation between LDH control statuses across visits. The dependent variable was the binary indicator for hemolysis control. Independent variables are categorical effects of visits, continuous baseline LDH. |
| Primary | Difference in Percentage of Participants With Transfusion Avoidance (TA) From Baseline Through Week 25 and Within 24 Weeks Prior to Screening | 24 Weeks Prior to Screening, Baseline to Week 25 | TA was defined as participants who were packed red blood cell (pRBC) transfusion-free and did not require transfusion per protocol-specified guidelines. TA within 24 weeks prior to screening was based on the pRBC transfusion history in the medical records. Reported in this outcome measure is the difference in the percentage of participants between "baseline through Week 25" and "within 24 weeks prior to screening". 95% Confidence Interval (CI) for the difference between the percentage of participants with transfusion avoidance between Pre-screening and Post-baseline is calculated using the Newcombe method. Screening= Day -28 to Day -1 and Baseline= Day 1. |
| Secondary | Percentage of Participants With Breakthrough Hemolysis (BTH) | Baseline, Week 25 | BTH was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath \[dyspnea\], anemia \[hemoglobin \< 10 grams per deciliter (g/dL)\], major adverse vascular event \[MAVE, including thrombosis\], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2xULN after a prior LDH reduction to ≤1.5xULN from the start of study treatment. As pre-specified in the SAP participants withdrawing before Week 25 were deemed to have experienced a BTH event. Percentages have been rounded off to the first decimal point. |
| Secondary | Percentage of Participants With Stabilized Hemoglobin | Baseline, Week 25 | Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from baseline, in the absence of transfusion. As pre-specified in the SAP participants withdrawing before Week 25 were deemed to not have hemoglobin stabilization. |
| Secondary | Change From Baseline in Fatigue in Adults Aged >=18 Years | Baseline, Week 2, Week 5, Week 9, Week 17, Week 25 | Fatigue was assessed using functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. FACIT-F is a self-assessment questionnaire with a 7-day recall period and 13 items evaluating fatigue and its impact on daily life activities. Items are scored on a response scale that ranges from 0 ("not at all") to 4 ("very much so"). Relevant items are reverse scored, and all the items are summed to create a total score range from 0 to 52, with 0 being the worst possible score and 52 being the best possible score. A higher score indicates low fatigue severity. A positive mean change indicates improvement. FACIT-F was assessed in adult participants only. FACIT-F assessment was unintentionally missed in the Schedule of Activities (SoA) table, which site used to guide the assessments at each timepoint. Therefore, data were not collected at Week 25. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | Up to 7 years | |
| Secondary | Percentage of Participants With Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity, and Infections (Including Meningococcal Meningitis) | Up to 7 years | |
| Secondary | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | Up to 7 years | |
| Secondary | Trough Serum Concentration of Crovalimab Over Time | Up to 7 years | |
| Secondary | Serum Concentrations of Crovalimab | Up to 7 years | |
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) to Crovalimab | Up to 7 years | |
| Secondary | Terminal Complement Activity as Measured by Liposome Immunoassay (LIA) | Up to 7 years | |
| Secondary | Change Over Time in Total and Free C5 Concentration | Up to 7 years | |
| Secondary | Observed Value in Absolute Reticulocyte Count | Up to 7 years | |
| Secondary | Observed Value in Free Hemoglobin | Up to 7 years | |
| Secondary | Observed Value in Haptoglobin | Up to 7 years | |
| Secondary | Percent Change From Baseline in Absolute Reticulocyte Count | Baseline, Week 25 | |
| Secondary | Percent Change From Baseline in Free Hemoglobin | Baseline, Week 25 | |
| Secondary | Percent Change From Baseline in Haptoglobin | Baseline, Week 25 |
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.
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