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Porovnat účinnost přidání methotrexátu (MTX) k současnému standardnímu akutnímu onemocnění štěpu proti hostiteli (GVHD) první linii léčby kortikosteroidy (MTX-aGVHD)

15. září 2026 aktualizováno: Assistance Publique - Hôpitaux de Paris

Multicentrická randomizovaná ve dvojitě zaslepené studii fáze III srovnávající samotnou terapii standardní péče s kortikosteroidy a nízkou dávkou metotrexátu (MTX) pro léčbu první linie akutního onemocnění štěpu proti hostiteli po alogenní transplantaci kmenových buněk

Phase III randomized double-blinded trial designed to compare the efficacy of the addition of MTX to current standard acute GVHD first-line treatment with corticosteroids. The protocol will use a novel endpoint for benchmarking interventions based on a composite primary endpoint of GVHD-free and corticosteroids-free survival.

The primary endpoint of the trial will be the assessment of a composite endpoint of graft-versus-host disease-free and corticosteroids-free survival at 12 months after randomization

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This is a phase III randomized, multicenter, double blinded controlled study. Patients who develop clinically meaningful acute GVHD and who meet all other entry criteria will be randomized 1:1 to receive either corticosteroids and placebo ("standard of care", control arm) or the combination of low-dose MTX with corticosteroids as first-line therapy for acute GVHD (MTX; "experimental arm").

The primary analysis of this hypothesis generation study is to estimate the composite endpoint of GVHD-free and corticosteroids-free survival at 12 months after randomization in both treatment arms. In fact, it is more and more established that such composite endpoint is a clinically very relevant one because it represents ideal recovery from allo-SCT (Stem Cell transplantation) (at 1 year after acute GVHD diagnosis) and a measure of cure without ongoing morbidity.

Typ studie

Intervenční

Zápis (Aktuální)

104

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Francie
      • Paris, Francie, 75012
        • Saint Antoine Hospital - Hematology Department

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Adults patients (>=18 years old) with hematological diseases, who develop a first episode of acute GVHD (grade II-IV) requiring systemic therapy
  • First allo-SCT, with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
  • Biopsy of acute GVHD target organ is recommended, but not required. Enrollment should not be delayed awaiting biopsy or pathology results
  • The patient must have received no previous systemic immune suppressive therapy for treatment of acute GVHD, except for a maximum 72 hours of prior corticosteroid therapy
  • Absolute neutrophil count (ANC) greater than 0.5 G/L
  • Platelets count greater than 20 G/L
  • Signed informed consent
  • Affiliation to a social security system (recipient or assign)
  • Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception until 6 months after the end of treatment.

Men with a partner of childbearing potential must agree to use a medically acceptable method of contraception until 6 months after the end of treatment.

Exclusion Criteria:

  • Hyper-acute GVHD as defined by the MD Anderson's criteria (Saliba, de Lima et al. 2007)
  • Flare of GVHD in a patient already on corticosteroid treatment
  • Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia, Greinix et al. 2015)
  • MTX given within 7 days of enrollment
  • Active uncontrolled infection
  • Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
  • Acute GVHD after donor lymphocytes infusion (DLI)
  • Other systemic drugs for GVHD treatment (including extra-corporeal photopheresis)
  • If any prior steroid therapy (for indication other than GVHD), treatment at doses > 0.5 mg/kg/day methyl-prednisolone within 7 days prior to onset of acute GVHD
  • Patients who are pregnant, breast feeding, or if sexually active, unwilling to use effective birth control for the duration of the study
  • Patient on dialysis
  • Patients with veno-occlusive disease of the liver or with significant liver abnormalities who in the judgment of the treating physician cannot receive MTX
  • Patients requiring after inclusion in the protocol the continuation of one or more of the following medication: probenecide, trimethoprime (alone or in combination with sulfametoxazole), phenylbutazone or yellow fever vaccine
  • Patients with a history of intolerance/allergy to MTX
  • Hypersensitivity to the active substance or to any of the excipients

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Methotrexate
  • 3mg/Kg/day methotrexate for 4 weeks then 3 mg/m2 every two weeks for 12 weeks
  • 2mg/kg/day PO prednisone prednisone (or 1.6 mg/kg/day IV methylprednisolone) once daily.
  • 10 mg po or iv lederfolin after each MTX administration
Lék: Methotrexate

Methotrexate 3 mg/m2 will be given once week for 4 weeks, then 3 mg/m2 every two weeks for 12 weeks. Body surface area will be capped at 2 m2.

Methotrexate will be given as an IV infusion over 15 minutes. All patients will received prednisone 2 mg/kg.day PO (or methylprednisolone 1.6 mg/Kg/day) for 3 days.

For responding patients between day 4 and 28, the dose of prednisone must be at least 0.25 mg/kg/day prednisone (or 0.2 mg/kg/day methylprednisolone).

All patients should receive a folinic acid supplementation 24 hours after each MTX/placebo administration.

Lederfoldin 10 mg po or iv will be administered on days 2, 9, 16 and 23. Lederfoldin 10 mg po or iv will be administered on days 37, 51, 65, 79, 93 and 103.
Komparátor placeba: Placebo
  • Once a week placebo for 4 weeks then every two weeks for 12 weeks
  • 2 mg/kg/day PO prednisone (or 1.6 mg/kg/day IV methylprednisolone) once daily.
  • 10 mg po or iv lederfolin after each placebo administration
Lék: Placebo

Placebo 3 mg/m2 will be given once week for 4 weeks, then 3 mg/m2 every two weeks for 12 weeks. Body surface area will be capped at 2 m2.

Placebo will be given as an IV infusion over 15 minutes. All patients will received prednisone 2 mg/kg.day PO (or methylprednisolone 1.6 mg/Kg/day) for 3 days.

For responding patients between day 4 and 28, the dose of prednisone must be at least 0.25 mg/kg/day prednisone (or 0.2 mg/kg/day methylprednisolone).

All patients should receive a folinic acid supplementation 24 hours after each MTX/placebo administration.

Lederfoldin 10 mg po or iv will be administered on days 2, 9, 16 and 23. Lederfoldin 10 mg po or iv will be administered on days 37, 51, 65, 79, 93 and 103.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization.
Časové okno: Evaluation will be performed at time of inclusion

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at time of inclusion
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (1).
Časové okno: Evaluation will be performed before start of MTX at the randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed before start of MTX at the randomization.
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (2).
Časové okno: Evaluation will be performed at Day 8

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 8
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (3).
Časové okno: Evaluation will be performed at Day 15

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 15
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (4).
Časové okno: Evaluation will be performed at Day 22

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 22
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (5).
Časové okno: Evaluation will be performed at Day 28

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 28
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (6).
Časové okno: Evaluation will be performed at Day 36

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 36
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (7).
Časové okno: Evaluation will be performed at Day 50

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 50
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (8).
Časové okno: Evaluation will be performed at Day 56

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 56
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (9).
Časové okno: Evaluation will be performed at Day 64

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 64
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (10)
Časové okno: Evaluation will be performed at Day 78

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 78
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (11).
Časové okno: Evaluation will be performed at Day 92

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 92
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (12).
Časové okno: Evaluation will be performed at Day 102

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 102
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (13).
Časové okno: Evaluation will be performed at 5 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 5 months after randomization.
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (14).
Časové okno: Evaluation will be performed at 6 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 6 months after randomization.
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (17).
Časové okno: Evaluation will be performed at 9 months after randomization .

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 9 months after randomization .
Assessment of a composite endpoint of graft-versus-host disease-free at 12 months after randomization (18).
Časové okno: Evaluation will be performed at 12 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 12 months after randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (19).
Časové okno: Evaluation will be performed at time of inclusion.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at time of inclusion.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (20).
Časové okno: Evaluation will be performed before start of MTX at the randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed before start of MTX at the randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (21).
Časové okno: Evaluation will be performed at Day 8.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 8.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (20).
Časové okno: Evaluation will be performed at Day 15.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 15.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (21).
Časové okno: Evaluation will be performed at Day 22.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 22.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (22).
Časové okno: Evaluation will be performed at Day 28.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 28.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (23).
Časové okno: Evaluation will be performed at Day 36

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 36
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (24).
Časové okno: Evaluation will be performed at Day 50.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 50.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (25).
Časové okno: Evaluation will be performed at Day 56.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 56.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (26).
Časové okno: Evaluation will be performed at Day 64.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 64.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (27).
Časové okno: Evaluation will be performed at Day 78.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 78.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (28).
Časové okno: Evaluation will be performed at D92.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at D92.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (29).
Časové okno: Evaluation will be performed at Day 102.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at Day 102.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (30).
Časové okno: Evaluation will be performed at 5 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 5 months after randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (31).
Časové okno: Evaluation will be performed at 6 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 6 months after randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (32).
Časové okno: Evaluation will be performed at 9 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 9 months after randomization.
Assessment of a composite endpoint of corticosteroids-free survival at 12 months after randomization (33).
Časové okno: Evaluation will be performed at 12 months after randomization.

GVHD-free survival is defined as absence of initiation of additional GVHD therapy or development of chronic GVHD requiring systemic therapy, and corticosteroids-free survival as absence of continuation of corticosteroids above a dose of 0.15 mg/Kg day.
Evaluation will be performed at 12 months after randomization.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Výskyt závažných nežádoucích účinků během prvních 12 měsíců po randomizaci
Časové okno: 12 měsíců po randomizaci
12 měsíců po randomizaci
Podíl kompletní remise (CR), velmi dobré částečné odpovědi (VGPR), částečné odpovědi (PR), smíšené odpovědi (MR), žádné odpovědi (NR) a progrese v den 28, den 56 a nejlepší odpověď během prvních 12 měsíců po randomizaci.
Časové okno: v den 28, den 56 a nejlepší odpověď během prvních 12 měsíců po randomizaci.
v den 28, den 56 a nejlepší odpověď během prvních 12 měsíců po randomizaci.
Podíl vzplanutí GVHD během prvních 12 měsíců po randomizaci.
Časové okno: 12 měsíců po randomizaci
12 měsíců po randomizaci
Kumulativní incidence celkové a závažné chronické GVHD podle NIH Consensus Criteria během prvních 12 měsíců po randomizaci (Jagasia, Greinix et al. 2015, Lee, Wolff et al. 2015).
Časové okno: během prvních 12 měsíců po randomizaci
během prvních 12 měsíců po randomizaci
Výskyt systémové infekce a reaktivace CMV (cytomegalovirus) během 3 měsíců po randomizaci
Časové okno: do 3 měsíců po randomizaci
do 3 měsíců po randomizaci
Výskyt reaktivace EBV (virus Epstein-Barrové) a potransplantačního lymfoproliferativního onemocnění během 12 měsíců po randomizaci
Časové okno: do 12 měsíců po randomizaci
do 12 měsíců po randomizaci
Kumulativní incidence nerecidivující mortality během prvních 12 měsíců po randomizaci.
Časové okno: 12 měsíců po randomizaci
12 měsíců po randomizaci
Bez kortikosteroidů, bez onemocnění a celkové přežití během prvních 12 měsíců po randomizaci.
Časové okno: 12 měsíců po randomizaci
12 měsíců po randomizaci
Imunitní zotavení a mikroflóra: počet pacientů s kompletním imunitním zotavením (lymfocyty a dendritické buňky) a úpravou dysbiózy mikroflóry během prvních 12 měsíců
Časové okno: 12 měsíců po randomizaci
12 měsíců po randomizaci
Quality of Life (QoL)-1
Časové okno: 12 Months

Evaluation by 1 questionnaire: EORTC QLQ-C30 (quality of life questionnaire) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30)
12 Months
Quality of Life (QoL)-2
Časové okno: 12 Months

Evaluation by 1 questionnaire: FACT-BMT (Functional Assessment of Cancer Therapy - Bone Marrow Transplant)
12 Months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Assistance Publique - Hôpitaux de Paris

Vyšetřovatelé

  • Vrchní vyšetřovatel: Mohamad Mohty, PU-PH, Assistance Publique - Hôpitaux de Paris

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

16. srpna 2018

Primární dokončení (Aktuální)

24. ledna 2025

Dokončení studie (Aktuální)

24. ledna 2025

Termíny zápisu do studia

První předloženo

31. července 2017

První předloženo, které splnilo kritéria kontroly kvality

12. prosince 2017

První zveřejněno (Aktuální)

13. prosince 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PHRC-K 16-150
  • 2017 (Grant/smlouva NIH USA)
  • 2017-002691-98 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

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Ne

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