ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
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|ClinicalTrials.gov Identifier: NCT03056040|
Recruitment Status : Active, not recruiting
First Posted : February 16, 2017
Last Update Posted : March 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Nocturnal Hemoglobinuria (PNH)||Biological: ALXN1210 Biological: Eculizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||197 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab|
|Actual Study Start Date :||June 5, 2017|
|Actual Primary Completion Date :||March 8, 2018|
|Estimated Study Completion Date :||March 2020|
Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
|Active Comparator: Eculizumab||
Regular maintenance dosing beginning on Day 1, then every 2 weeks to Day 183.
Single loading dose of ALXN1210 on Day 183, followed by regular maintenance dosing beginning on Day 197, based on weight.
- Hemolysis as directly measured by percentage change in LDH levels [ Time Frame: 26 weeks ]The difference between treatment arms in LDH-PCHG from Baseline to Day 183
- Change from baseline in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [ Time Frame: 26 weeks ]Change in quality of life as assessed by the FACIT-Fatigue scale will be compared between the treatment groups from Baseline to Day 183
- Percentage of patients who achieve Transfusion Avoidance (TA) [ Time Frame: 26 weeks ]The proportion of patients who remain transfusion-free will be compared between treatment groups from Baseline to Day 183
- Percentage of patients with stabilized hemoglobin [ Time Frame: 26 weeks ]The percentage of patients with stabilized hemoglobin will be compared between the treatment groups from Baseline to Day 183.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056040
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