Trial · NCT05096403
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving a Response (R) at Week 24 | Week 24 | A participant was considered to have a response if the Hgb level increased greater than or equal to (\>=) 1.5 gram per deciliter (g/dL) from baseline and this increase was maintained from Week 16 through Week 24 in absence of blood transfusion from Week 5 through Week 24. |
| Secondary | Change From Baseline to Week 24 in Hemoglobin (Hgb) Level-Part A in the Absence of Intercurrent Events (ICEs). | Week 24 | The ICEs of interest were : * Withdrawal from treatment or lost to follow-up before the end of the double-blind period * Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange) Mean change from Baseline to Week 24 in Hemoglobin (Hgb) level. |
| Secondary | Number of Patients Achieving Transfusion Avoidance From Week 5 to Week 24-Part A | Week 24 | Percentage of patients who did not receive a blood transfusion between Week 5 and Week 24 was assessed |
| Secondary | Change From Baseline to Week 24 in FACT-An Scale Score (Quality of Life)-Part A in the Absence of Intercurrent Events (ICEs) | Week 24 | The ICEs of interest were : * Withdrawal from treatment or lost to follow-up before the end of the double-blind period * Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange). FACT-An is used to measure quality of life (QoL) in patients with anemia. Each item is rated on a 5-point Likert scale:0=Not at all, 1=A little bit ,2=Somewhat, 3=Quite a bit, 4=Very much. Some items are reverse scored. Higher scores in this scale denote a better QoL with less impact of anemia.The total FACT-An scale score ranges from 0 to 160. The total score gives a comprehensive view of a patient's well-being. It combines the FACT-G with an Anemia subscale. FACT-G (27 items):Physical Well-Being (PWB) and Social/Family Well-Being (SWB) 14 items in total, Emotional Well-Being (EWB)-6 items,Functional Well-Being (FWB)-7 items, Anemia Subscale (AnS): 13 items. Total FACT-An score=FACT-G + Anemia Subscale=40 item |
| Secondary | Number of Packed Red Blood Cell Transfusions Received by Patients From Week 5 to Week 24-Part A | Week 24 | Number of blood transfusions received between Week 5 and Week 24 were assessed. |
| Secondary | Change From Baseline to Week 24 in LDH Levels-Part A in the Absence of Intercurrent Events (ICEs) | Week 24 | The ICEs of interest were : * Withdrawal from treatment or lost to follow-up before the end of the double-blind period * Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange) Mean change from baseline to Week 24 in Lactate dehydrogenase (LDH) levels |
| Secondary | Change From Baseline to Week 24 in Haptoglobin Levels-Part A in the Absence of Intercurrent Events (ICEs) | Week 24 | The ICEs of interest were : * Withdrawal from treatment or lost to follow-up before the end of the double-blind period * Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange). Mean change from baseline to Week 24 in Haptoglobin level |
| Secondary | Change From Baseline to Week 24 in Indirect Bilirubin-Part A in the Absence of Intercurrent Events (ICE) | Week 24 | The ICEs of interest were : * Withdrawal from treatment or lost to follow-up before the end of the double-blind period * Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange). Mean change from baseline to Week 24 in Indirect bilirubin level |
| Secondary | Change From Baseline to Week 24 in ARC-Part A in the Absence of Intercurrent Events (ICEs) | Week 24 | The ICEs of interest were : * Withdrawal from treatment or lost to follow-up before the end of the double-blind period * Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange). Mean change from baseline to Week 24 in Absolute reticulocyte counts (ARC). |
| Secondary | Change From Baseline to Week 24 in D-dimer Levels-Part A in the Absence of Intercurrent Events (ICEs | Week 24 | * Withdrawal from treatment or lost to follow-up before the end of the double-blind period * Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange) change from baseline to Week 24 in D-dimer levels. |
| Secondary | Normalization of Markers of Hemolysis (LDH) at Week 24-Part A | Week 24 | Percentage of patients with LDH level within normal ranges and with an abnormal value at baseline. |
| Secondary | Normalization of Markers of Hemolysis (Indirect Bilirubin) at Week 24-Part A | Week 24 | Percentage of patients with Indirect Bilirubin level within normal ranges and with an abnormal value at baseline. |
| Secondary | Normalization of Markers of Hemolysis (ARC) at Week 24-Part A | Week 24 | Percentage of patients with ARC level within normal ranges and with an abnormal value at baseline. |
| Secondary | Normalization of Markers of Hemolysis (Haptoglobin) at Week 24-Part A | Week 24 | Percentage of patients with haptoglobin level within normal ranges and with an abnormal value at baseline. |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for Haptoglobin Levels-Part A | Week 24 | Percentage of patients with haptoglobin level normalization during the initial 24 weeks of the study |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for Hemoglobin Levels-Part A | Week 24 | Percentage of patients with Hemoglobin level normalization during the initial 24 weeks of the study |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for LDH Levels-Part A | Week 24 | Percentage of patients with LDH level normalization during the initial 24 weeks of the study |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for Indirect Bilirubin Levels-Part A | Week 24 | Percentage of patients with Indirect Bilirubin level normalization during the initial 24 weeks of the study |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for ARC Levels-Part A | Week 24 | Percentage of patients with ARC level normalization during the initial 24 weeks of the study |
| Secondary | Number of Packed Red Blood Cell Units Transfused From Week 5 to Week 24-Part A | Week 5 to Week 24 | Number of PRBC units transfused from Week 5 and Week 24 was assessed |
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
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