Ravulizumab ved trombotisk mikroangiopati efter hæmatopoietisk stamcelletransplantation
En fase 3, randomiseret, dobbeltblind, placebokontrolleret, multicenterundersøgelse af Ravulizumab hos voksne og unge deltagere, der har trombotisk mikroangiopati (TMA) efter hæmatopoietisk stamcelletransplantation (HSCT)
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Parkville, Australien, 3050
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Bruges, Belgien, 8000
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Brussels, Belgien, 1200
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Chênée, Belgien, 4032
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Yvoir, Belgien, 5530
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Cerqueira César, Brasilien, 05403-000
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Florianópolis, Brasilien, 88034-000
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Jaú, Brasilien, 17210-080
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Porto Alegre, Brasilien, 90110-270
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Porto Alegre, Brasilien, 90035-903
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Rio de Janeiro, Brasilien, 20230-130
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São José do Rio Preto, Brasilien, 15090-000
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São Paulo, Brasilien, 05.403-010
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
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London, Det Forenede Kongerige, W12 0HS
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Nottingham, Det Forenede Kongerige, NG5 1PB
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Florida
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Tampa, Florida, Forenede Stater, 33612
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Michigan
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Grosse Pointe Farms, Michigan, Forenede Stater, 48236
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North Carolina
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Durham, North Carolina, Forenede Stater, 27705
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
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Washington
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Seattle, Washington, Forenede Stater, 98109
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Angers, Frankrig, 49033
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La Tronche, Frankrig, 38043
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Nice, Frankrig, 06200
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Athens, Grækenland, 12462
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Pátrai, Grækenland, 26504
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Thessaloniki, Grækenland, 57010
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Groningen, Holland, 9713 GZ
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Halfa, Israel, 31096
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Ramat Gan, Israel, 52621
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Roma, Italien, 00168
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Udine, Italien, 33100
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Akita, Japan, 010-8543
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Anjo, Japan, 446-8602
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Chiba, Japan, 260-8677
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Fukushima, Japan, 960-1295
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Isehara-shi, Japan, 259-1193
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Kurashiki-shi, Japan, 710-8602
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Minatoku, Japan, 105-8470
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Okayama, Japan, 700-8558
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Osaka, Japan, 545-8586
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Osakasayama-shi, Japan, 589-8511
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Sapporo, Japan, 060-8638
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Suita-shi, Japan, 565-0871
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Tsukuba, Japan, 305-8576
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Wakayama, Japan, 641-8510
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Suzhou, Kina, 215006
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Tianjin, Kina, 300020
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Barcelona, Spanien, 08036
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Granada, Spanien, 18014
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L'Hospitalet de Llobregat, Spanien, 08908
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Madrid, Spanien, 28034
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Madrid, Spanien, 28046
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Madrid, Spanien, 28040
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Madrid, Spanien, 28007
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Málaga, Spanien, 29010
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Pamplona, Spanien, 31008
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Salamanca, Spanien, 37007
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Seville, Spanien, 41013
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Huddinge, Sverige, 141 57
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Goyang-si, Sydkorea, 10408
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Seoul, Sydkorea, 03080
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Seoul, Sydkorea, 03722
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Seoul, Sydkorea, 06351
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Hamburg, Tyskland, 20246
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Ulm, Tyskland, 89081
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 12 years of age or older at time of consent/assent.
- Received HSCT within the past 12 months.
- Diagnosis of TMA that persists for at least 72 hours after initial management of any triggering agent/condition.
- A TMA diagnosis based on meeting the laboratory-based criteria during the Screening Period and/or ≤14 days prior to the Screening Period.
- Body weight ≥ 30 kilograms at Screening or ≤7 days prior to the start of the Screening Period (date of consent).
- Female participants of childbearing potential and male participants with female partners of childbearing potential must use highly effective contraception.
- Participants must be vaccinated against meningococcal infections if clinically feasible. Participants who cannot receive meningococcal vaccine should receive antibiotic prophylaxis. Participants <18 years of age must be re-vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae if clinically feasible.
- Participants or their legally authorized representative must be capable of giving signed informed consent or assent.
Exclusion Criteria:
- Thrombotic thrombocytopenic purpura (TTP) evidenced by ADAMTS13 deficiency
- Known Shiga toxin-related hemolytic uremic syndrome as demonstrated by positive test.
- Positive direct Coombs test indicative of a clinically significant immune-mediated hemolysis not due to TMA.
- Clinical diagnosis of disseminated intravascular coagulation (DIC).
- Known bone marrow/graft failure for the current HSCT.
- Diagnosis of veno-occlusive disease which is unresolved at the time of Screening.
- Human immunodeficiency virus (HIV) infection.
- Unresolved meningococcal disease.
- Presence of sepsis requiring vasopressor support.
- Pregnancy or breastfeeding.
- Hypersensitivity to murine proteins or to one of the excipients of ravulizumab.
- Any ongoing or history of medical or psychological conditions unrelated to HSCT-TMA that could increase the risk to the participant or confound the outcome of the study.
- Respiratory failure requiring mechanical ventilation.
- Acute and/or chronic heart failure with an ejection fraction ≤ 40%.
- Previously or currently treated with a complement inhibitor.
- Participation in an interventional treatment study of any therapy for TMA.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Ravulizumab
In Stage 1, all participants will receive open-label ravulizumab plus Best Supportive Care (BSC). In Stage 2, participants will receive blinded ravulizumab plus Best Supportive Care (BSC). |
Weight-based doses of ravulizumab will be administered intravenously as loading dose regimen followed by maintenance dosing every 8 weeks.
Andre navne:
Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol). |
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Placebo komparator: Placebo
In Stage 2, participants randomized to the placebo arm will receive matching placebo plus BSC. |
Matching placebo Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Stage 2: Proportion of Participants With Event-free Survival During the 26-week Treatment Period
Tidsramme: Up to Week 26
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Event-free survival was defined as the time from randomization until the first of the 2 following events: death (due to any cause) and clinical worsening up through Week 26. Clinical worsening was defined as meeting 2 or more of the following criteria: doubling of serum creatinine from baseline or new requirement of dialysis; increase in lactate dehydrogenase (LDH) >25% compared to baseline; reduction in platelets of >25% compared to baseline; reduction in hemoglobin >10% compared to baseline; increased requirement for platelets or red blood cells at any time. The criteria for clinical worsening had to be confirmed by 2 independent samples collected at least 8 hours apart (ideally 24 hours apart). |
Up to Week 26
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Stage 2: Overall Survival
Tidsramme: Up to Day 100 (Treatment Period), Week 26 (Treatment Period), and Week 52 (Follow-up Period)
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The Kaplan-Meier method was used to measure overall survival estimate. For Day 100 and Week 26, overall survival was calculated from randomization to death (due to any cause), up to Day 100/Week 26. Participants who survived were censored at the earliest of an additional hematopoietic stem cell transplant (HSCT), Day 100/Week 26, or their last known date alive. For Week 52, overall survival was calculated from randomization to death (due to any cause), up to Week 52. Participants who survived were censored at the earlier of an additional HSCT, or their last known date alive up to Week 52. |
Up to Day 100 (Treatment Period), Week 26 (Treatment Period), and Week 52 (Follow-up Period)
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Stage 2: Non-relapse Mortality
Tidsramme: Baseline through Day 100 (Treatment Period), Week 26 (Treatment Period), and Week 52 (Follow-up Period)
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Cumulative incidence for each group was estimated using a competing risks model. Non-relapse mortality was defined as a participant's death due to any cause during the study, with the exception of death due to underlying disease (malignant or non-malignant reason for HSCT) progression or relapse. |
Baseline through Day 100 (Treatment Period), Week 26 (Treatment Period), and Week 52 (Follow-up Period)
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Stage 2: Mean Number of Thrombotic Microangiopathy (TMA) Response Criteria Met During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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The TMA response parameters included: platelet response, normalization of LDH and absence of schistocytes, and renal response. A participant could have met 0, 1, 2, or 3 TMA response criteria during the 26-week Treatment Period. If the participants met more than 1 TMA response criterion, the number of responses overlapping for at least 24 hours was counted. Least squares mean determined from a general linear model adjusted by acute GVHD status and geographic region, assuming normal data distribution. |
Baseline through Week 26
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Stage 2: Percentage of Participants With Hematologic Response During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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Clinical laboratory assessments were performed according to the protocol and assessed against the following predetermined criteria for hematologic response: if baseline platelet count was ≤50000/cubic millimeter (mm^3), then the absolute platelet count had to be >50000/mm^3 without platelet transfusion support during the prior 7 days; if the baseline platelet count had to be >50000/mm^3, then there must be a ≥50% increase in platelet count compared to baseline value without platelet transfusion support during the prior 7 days; normalization of LDH and absence of schistocytes (defined as ≤1% or a result of "none", per the International Council for Standardization in Hematology recommendations for schistocyte counting). |
Baseline through Week 26
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Stage 2: Change From Baseline in the Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 52
Tidsramme: Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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The eGFR was calculated based on serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula. Serum creatinine was collected according to the protocol. Data reported as milliliters/minute/1.73 square meters (mL/min/1.73 m^2). |
Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Stage 2: Percentage of Participants With TMA Response During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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The criteria for TMA response included a hematological response and a renal response. Hematological Response: if baseline platelet count was ≤50000/mm^3, then the absolute platelet count had to be >50000/mm^3 without platelet transfusion support during the prior 7 days; if the baseline platelet count was >50000/mm^3, then there had to be a ≥50% increase in platelet count compared to baseline value without platelet transfusion support during the prior 7 days; normalization of LDH and absence of schistocytes. Renal response: at least 50% reduction of proteinuria from baseline. Participants must have met each of the response criteria, with each parameter meeting the requirements at 2 separate assessments obtained at least 24 hours apart, and any measurement in between. A participant could meet 0, 1, 2, or 3 TMA response criteria during the treatment period. If the participant met more than 1 TMA response criterion, the number of responses overlapping for at least 24 hours was counted. |
Baseline through Week 26
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Stage 2: Cumulative Proportion of Participants Who Experienced a Complete TMA Response During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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Cumulative proportion of participants who experienced a complete TMA response was estimated using a competing risks model based on the time (days) to complete TMA response. Time to complete TMA response was defined as the days from randomization to the first day during the 26-week Treatment Period on which a participant met all criteria for a complete TMA response. The date of complete TMA response was defined as the first date on which all individual response criteria were met simultaneously. |
Baseline through Week 26
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Stage 2: Cumulative Proportion of Participants Experiencing Each Individual Component of TMA During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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Cumulative proportion of participants experiencing individual TMA components included those for platelet count, LDH, and protein/creatinine ratio. For platelet count: if baseline platelet count was ≤50000/mm^3, then the absolute platelet count had to be >50000/mm^3 without platelet transfusion support during the prior 7 days; if the baseline platelet count was >50000/mm^3, then there had to be a ≥50% increase in platelet count compared to baseline value without platelet transfusion support during the prior 7 days. For LDH: normalization of LDH and absence of schistocytes. For protein/creatinine ratio: at least 50% reduction of proteinuria from baseline. |
Baseline through Week 26
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Stage 2: Cumulative Proportion of Participants Experiencing a Hematologic Response During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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Clinical laboratory assessments were performed according to the protocol and assessed against the following predetermined criteria for hematologic response: if baseline platelet count was ≤50000/mm^3, then the absolute platelet count had to be >50000/mm^3 without platelet transfusion support during the prior 7 days; if the baseline platelet count was >50000/mm^3, then there had to be a ≥50% increase in platelet count compared to baseline value without platelet transfusion support during the prior 7 days. |
Baseline through Week 26
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Stage 2: Percentage of Participants With Hemoglobin Response During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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Hemoglobin response was defined as the ability to maintain hemoglobin ≥10 grams/deciliter (g/dL) without any support. The criterion had to be met at 2 separate assessments obtained at least 24 hours apart, and any measurement in between, and without any support during the prior 7 days. |
Baseline through Week 26
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Stage 2: Percentage of Participants With Platelet Response During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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Platelet response was defined as: if baseline platelet count was ≤50000/mm^3, then the absolute platelet count had to be >50000/mm^3 without platelet transfusion support during the prior 7 days; if the baseline platelet count was >50000/mm^3, then there had to be a ≥50% increase in platelet count compared to baseline value without platelet transfusion support during the prior 7 days. The criteria had to be met at 2 separate assessments obtained at least 24 hours apart, and any measurement in between. |
Baseline through Week 26
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Stage 2: Percentage of Participants With Partial Response During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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The criteria for TMA response included a hematological response and a renal response. Hematological response: if baseline platelet count was ≤50000/mm^3, then the absolute platelet count had to be >50000/mm^3 without platelet transfusion support during the prior 7 days; if the baseline platelet count was >50000/mm^3, then there had to be a ≥50% increase in platelet count compared to baseline value without platelet transfusion support during the prior 7 days; normalization of LDH and absence of schistocytes. Renal response: at least 50% reduction of proteinuria from baseline. Partial response occurred when the participant met ≥1, but not all, criteria for TMA response. |
Baseline through Week 26
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Stage 2: Percentage of Participants With Loss of TMA Response During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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For participants that met the criteria for TMA response during the 26-week Treatment Period, loss of TMA response was defined as when the participant failed to meet the criteria for 1 or more components of TMA response at a subsequent visit during the 26-week Treatment Period. At least 1 parameter must have failed to meet the response criteria at 2 separate assessments obtained at least 24 hours apart, and any measurement in between. |
Baseline through Week 26
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Stage 2: Duration of TMA Response
Tidsramme: Baseline through Week 52
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This analysis includes data for each participant after achieving TMA response under the composite strategy through Weeks 26 and 52. The criteria for TMA response included a hematological response and a renal response. Time was calculated as the number of days from TMA response under the composite strategy to first loss of response or intercurrent event in the treatment period, or TMA relapse in the follow-up period. Participants must have met each of the response criteria, with each parameter meeting the requirements at 2 separate assessments obtained at least 24 hours apart, and any measurement in between. Participants with TMA response who did not experience these events were censored at their end of study date. The estimate is calculated based on the Kaplan-Meier method. Non-responders were counted as an event with a duration of zero day. |
Baseline through Week 52
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Stage 2: Change From Baseline in Haptoglobin at Week 26 and Week 52
Tidsramme: Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Protocol-specified blood samples were taken for the analysis of haptoglobin in plasma at designated time points. Results are reported as grams/liter (g/L). |
Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Stage 2: Change From Baseline in Platelets at Week 26 and Week 52
Tidsramme: Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Protocol-specified blood samples were taken for the analyses of platelets in plasma at designated time points. |
Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Stage 2: Change From Baseline in LDH at Week 26 and Week 52
Tidsramme: Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Protocol-specified blood samples were taken for the analyses of LDH in plasma at designated time points. Results are reported as units/liter (U/L). |
Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Stage 2: Change From Baseline in Hemoglobin at Week 26 and Week 52
Tidsramme: Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Protocol-specified blood samples were taken for the analyses of hemoglobin in plasma at designated time points. |
Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Stage 2: Percentage of Participants With Modified TMA Response During the 26-week Treatment Period
Tidsramme: Baseline through Week 26
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The modified criteria for TMA response included a hematological response and a renal response. Hematological Response: if baseline platelet count ≤50000/mm^3, then the absolute platelet count had to be >50000/mm^3 without platelet transfusion support during the prior 7 days; if baseline platelet count >50000/mm^3, then there had to be a ≥50% increase in platelet count compared to baseline value without platelet transfusion support during the prior 7 days; at least 50% reduction of LDH from baseline and absence of schistocytes or normalization of LDH and absence of schistocytes. Renal response: at least 50% reduction of proteinuria from baseline. Participants must have met each response criterion, with each parameter meeting the requirement at 2 separate assessments obtained at least 24 hours apart, and any measurement in between. |
Baseline through Week 26
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Stage 2: Change From Baseline in Number of Participants With TMA-associated Organ Dysfunction in the Renal System Through Week 26 and Week 52
Tidsramme: Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Renal dysfunction was defined as doubling of serum creatinine from baseline or requirement of dialysis. Requirements for dialysis included: at the baseline visit, if there was any dialysis within 5 days prior to the first dose of study treatment; at the post-baseline visit, if there was any dialysis within 5 days prior to the visit. Participants categorized as those experiencing no symptoms at baseline and those experiencing symptoms at baseline. |
Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Stage 2: Change From Baseline in Number of Participants With TMA-associated Organ Dysfunction in the Cardiopulmonary System Through Week 26 and Week 52
Tidsramme: Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Cardiopulmonary dysfunction was defined as the presence of cardiopulmonary symptoms (excluding hypertension) or use of any mechanical ventilation. Cardiopulmonary symptoms included, but were not limited to, pleural effusion, pulmonary edema, pericardial effusion, and serositis. The presence of cardiopulmonary symptoms at baseline and post-baseline visits were assessed and recorded on the electronic case report form (eCRF). Use of any ventilatory or respiratory support, including mechanical ventilation, was reported on the participant's Nonpharmacologic Therapies and Procedures eCRF page. Participants categorized as those experiencing no symptoms at baseline and those experiencing symptoms at baseline. |
Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Stage 2: Change From Baseline in Number of Participants With TMA-associated Organ Dysfunction in the Central Nervous System Through Week 26 and Week 52
Tidsramme: Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Central nervous system dysfunction was defined as confirmed posterior reversible encephalopathy syndrome, or any signs of headache, confusion, visual loss, or seizures at baseline and post-baseline visits, as recorded on the eCRF. Participants categorized as those experiencing no symptoms at baseline and those experiencing symptoms at baseline. |
Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Stage 2: Change From Baseline in Number of Participants With TMA-associated Organ Dysfunction in the Gastrointestinal System Through Week 26 and Week 52
Tidsramme: Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Gastrointestinal dysfunction was defined as presence of signs and symptoms of gastrointestinal involvement at baseline and post-baseline visits, including diarrhea, vomiting, pain, and bleeding as recorded on the eCRF. Participants categorized as those experiencing no symptoms at baseline and those experiencing symptoms at baseline. |
Baseline, Week 26 (Treatment Period), Week 52 (Follow-up Period)
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Stage 2: Percentage of Participants With TMA Relapse
Tidsramme: Baseline through Week 52
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For participants that met the criteria for TMA response during the 26-week Treatment Period, TMA relapse was defined as evidence of worsening hematologic and renal dysfunction due to TMA during the post-treatment Follow-up Period and required treatment intervention, as determined by the investigator. |
Baseline through Week 52
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ALXN1210-TMA-313
- 2020-000144-61 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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