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A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care

16. října 2019 aktualizováno: Celgene

A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)

The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). The study will continue for 12 months following last patient enrolled.

See study AZA PH GL 2003 CL 001 E for information about the extension to this study.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Comparison/Control Interventions offered the physician three options:

  • Best supportive care (BSC) alone,
  • Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or
  • Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or mitoxantrone) on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to 70 days from the start of the previous cycle).

All three options included best supportive care. Neither the experimental group (azacitidine) nor any of the comparison/control options allowed use of erythropoietin.

Duration of Intervention: Patients will be treated until death, withdrawal, unacceptable toxicity or conclusion of the study.

Typ studie

Intervenční

Zápis (Aktuální)

358

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

  • Austrálie
    • New South Wales
      • Liverpool, New South Wales, Austrálie, 2170
        • Liverpool Hospital
      • St. Leonards, New South Wales, Austrálie, 2065
        • Royal North Shore Hospital
      • Warratah, New South Wales, Austrálie, 2298
        • The Newcastle Mater Miseriecordiae Hospital
    • Queensland
      • Hersten, Queensland, Austrálie, 4029
        • Royal Brisbane Hospital
      • Woolloongabba, Queensland, Austrálie, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Austrálie, 5000
        • Royal Adelaide Hospital
    • Victoria
      • East Melbourne, Victoria, Austrálie, 3002
        • Peter Maccallum Cancer Institute
      • Melbourne, Victoria, Austrálie, 3050
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Austrálie, 3181
        • The Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Austrálie, 6847
        • The Royal Perth Hospital
  • Bulharsko
      • Pleven, Bulharsko, 5800
        • First Clinical Base - Clinic of Hematology, MHAT - Pleven
      • Plovdiv, Bulharsko, 4004
        • III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)
      • Plovdiv, Bulharsko, 4002
        • MHAT "St George" Clinic of Hematology, Plovdiv
      • Sofia, Bulharsko, 1756
        • National Centre of Hematology and Transfusiology, Sofia
      • Varna, Bulharsko, 9010
        • University Multiprofile Hospital for Active Treatment "Sveta Marina"
      • Varna, Bulharsko, 3010
        • Multiprofile Hospital for Active Treatment (MHAT), "St. Marina" Clinic of Hematology
  • Francie
      • Angers, Francie, 49033
        • CHU d'Angers
      • Clichy, Francie, 92110
        • Hopital Beaujon
      • Lille, Francie, 59037
        • Che De Lille
      • Lyon, Francie, 69437
        • Hospital Edouard Herriot
      • Marseille, Francie, 13009
        • Institute Paoli Calmettes
      • Nantes, Francie, 44093
        • CHU de Nantes
      • Paris, Francie, 75679
        • Hôpital Cochin
      • Paris, Francie, 75010
        • Hospital Saint Louis
      • Rouen, Francie, 76038
        • Centre Henri Becquerel
      • Toulouse, Francie, 31059
        • CHU Purpan
  • Holandsko
      • Amsterdam, Holandsko, 1081 HV
        • VU University Medical Center Amsterdam
      • Nijmejen, Holandsko
        • Univ Hospital St. Radboud
  • Itálie
      • Bologna, Itálie, 40138
        • Policlinico S. Orsola-Malpighi
      • Firenze, Itálie, 50139
        • Universita Di Firenze
      • Genova, Itálie, I-16132
        • Ospedale San Martino
      • Milano, Itálie, 20133
        • Instituto Nazionale dei Tumori
      • Modena, Itálie, 41100
        • Centro Oncologico Modenese
      • Roma, Itálie, 00168
        • Policlinico Gemelli
      • Roma, Itálie, 00144
        • Ospedale San Eugenio
      • Roma, Itálie, 144
        • Instituto Nazionale Tumori "Regina Elena"
      • San Giovanni Rotondo, Itálie, 71013
        • Ospedale Casa Sollievo Della Sofferenza - Irrc
      • Sassari, Itálie, 7100
        • Università degli Studi di Sassari
  • Maďarsko
      • Budapest, Maďarsko, 1135
        • Orszagos Gyogyintezeti Kozpont
      • Pecs, Maďarsko, 7624
        • University of Pecs, 1st Dept of Internal Medicine
      • Szeged, Maďarsko, 6701
        • University of Szeged, 2nd Department of Internal Medicine
  • Německo
      • Bonn, Německo, 53105
        • Universitätsklinikum Bonn
      • Chemnitz, Německo, 9113
        • Klinikum Chemnitz gGmbH
      • Dresden, Německo, 1307
        • Universitatsklinikum Carl Gustav Carus
      • Duisburg, Německo, 47166
        • St Johannes Hospital
      • Dusseldorf, Německo, 40225
        • Heinrich-Heine University Düsseldorf
      • Essen, Německo, 45147
        • University Essen
      • Gottingen, Německo, 37075
        • Gerorg-August-Universitat Gottingen
      • Hamburg, Německo, D-20099
        • Allgemeines Krankenhaus St. Georg
      • Hamburg, Německo, D-20246
        • Universitatsklinikum Hambur-Eppendorf
      • Kiel, Německo, D-24116
        • Universitatsklinikum Kiel II
      • Ulm, Německo, 89070
        • Universitätsklinikum Ulm
    • Berlin
      • Hindenburgdamm, Berlin, Německo, D-12203
        • Universitatsklinikum Benjamin Franklin
  • Polsko
      • Gdansk, Polsko, 80-952
        • Samodzielny Publiczny Szpital Kliniczny Nr 1
      • Lodz, Polsko, 93-510
        • Wojewodzki Szpital Specjalistyczny
      • Lublin, Polsko, 20081
        • Samodzielny Publiczny Szpital Kliniczny
      • Warszawa, Polsko, 00-909
        • Wojskowy Instytut Medyczny
      • Warszawa, Polsko, 02-097
        • Samodzelny Publiczny Centralny Szpital Kliniczny
      • Wroclaw, Polsko, 50-367
        • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Ruská Federace
      • Moscow, Ruská Federace, 105299
        • Burdenko Central Military Clinical Hospital
      • Moscow, Ruská Federace, 115487
        • Blokhin Cancer Research Center
      • Moscow, Ruská Federace, 125167
        • Scientific Haematology Center, Moscow
      • St. Petersburg, Ruská Federace, 197089
        • Pavlov State Medical University
      • St. Petersburg, Ruská Federace, 197110
        • City Hospital #31
      • St. Petersburg, Ruská Federace, 193024
        • Institute of Haematology & Blood Transfusion
      • St. Petersburg, Ruská Federace, 197022
        • Pavlov State Medical University
  • Spojené království
      • Bournemouth, Spojené království, BH7 7DW
        • Royal Bournemouth General Hospital
      • London, Spojené království, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, Spojené království
        • Kings College Hospital NHS Trust
      • Manchester, Spojené království, M20 4BX
        • Christie Hospital
      • Norwich, Spojené království, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Oxford, Spojené království, OX3 9DU
        • John Radcliffe Hospital
      • Truro, Spojené království, TR1 3LJ
        • Royal Cornwall Hospital
  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35294
        • University of Alabama School of Medicine
    • Indiana
      • Indianapolis, Indiana, Spojené státy, 46202
        • Indiana University Cancer Center
    • Missouri
      • Saint Louis, Missouri, Spojené státy, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, Spojené státy, 10029-6574
        • Mount Sinai Medical Center
    • Ohio
      • Cleveland, Ohio, Spojené státy, 44106
        • Case Western Reserve University
    • Oregon
      • Portland, Oregon, Spojené státy, 97201
        • Oregon Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Spojené státy, 15224
        • Western Pennsylvania Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Spojené státy, 53226
        • Froedtert Memorial Lutheran Hospital
  • Česko
      • Olomouc, Česko, 775 20
        • Fakultni Nemocnice Olomouc
      • Praha, Česko, 2 128 08
        • Vseobecna Fakultni Nemocnice
      • Praha, Česko, 2 128 20
        • Uslav Hematologie a Krevni Transfuze
    • Brno
      • Jihlavska, Brno, Česko, 639 00
        • Fakultni nemocnice Brno
    • Hradec Kralove
      • Sokolska, Hradec Kralove, Česko, 500 05
        • Fakultni nemocnice Hradec Kralove
  • Řecko
      • Athens, Řecko, 11527
        • District General Hospital of Athens
      • Athens, Řecko, 11527
        • General Hospital of Chest Disease
      • Ioannina, Řecko, 45500
        • University General Hospital of Ioannina
      • Patra, Řecko, 26500
        • University General Hospital of Patra Rio
    • Athens
      • Haidari, Athens, Řecko, 12462
        • University Hospital-Attikon
    • Crete
      • Heraklio, Crete, Řecko, 71110
        • University General Hospital of Heraklio Voutes
  • Španělsko
      • Barcelona, Španělsko, 08036
        • Hospital Clinic
      • Barcelona, Španělsko, 08025
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Španělsko
        • Hospital Universitario Germans Trias i Pujol
      • Leon, Španělsko, 24071
        • Hospital de Leon
      • Madrid, Španělsko, 28006
        • Hospital Universitario de la Princesa
      • Madrid, Španělsko, 28034
        • Hospital Ramón Y Cajal
      • Madrid, Španělsko, 28046
        • Hospital La Paz, Madrid
      • Madrid, Španělsko, 28048
        • Hospital Clinico San Carlos
      • Palma de Mallorca, Španělsko, 07198
        • Hospital Son Llatzer
      • Salamanca, Španělsko, 37007
        • Hospital Universitario Del Salamanca
      • Valencia, Španělsko, 46009
        • Hospital Universitario La Fe
  • Švédsko
      • Goteborg, Švédsko, S-413 45
        • Sahlgrenska University Hospital
      • Lund, Švédsko, 22185
        • Lund Universtiy Hospital
      • Malmo, Švédsko, S-205 02
        • University Hospital MAS
      • Stockholm, Švédsko, 14186
        • Huddinge University Hospital
      • Uppsala, Švédsko, S-751 85
        • Uppsala University Hospital

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:

  • Have a diagnosis of refractory anemia with excess blasts or refractory anemia with excess blasts in transformation according to the French-American-British classification system for myelodysplastic syndromes (MDS) and a relatively high risk of acute myeloid leukemia (AML) transformation, with an International Prognostic Scoring System score of INT-2 or High.
  • Be 18 years of age or older
  • Have a life expectancy of at least 3 months
  • Be unlikely to proceed to bone marrow or stem cell transplantation therapy following remission
  • Have serum bilirubin levels less than or equal to 1.5 times the upper limit of normal range for the laboratory
  • Have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to 2 times the upper limit of normal (unless these are considered to be related to transfusion-induced secondary hemosiderosis)
  • Have serum creatinine levels less than or equal to 1.5 times the upper limit of normal

Exclusion Criteria:

  • Secondary myelodysplastic syndromes (MDS)
  • Prior treatment with azacitidine;
  • Prior history of acute myeloid leukemia (AML);
  • Malignant disease diagnosed within prior 12 months;
  • Metastatic disease;
  • Hepatic tumors;
  • Radiation, chemotherapy, cytotoxic therapy for non-MDS conditions within prior 12 months;
  • Prior transplantation or cytotoxic therapy to treat MDS;
  • Serious medical illness likely to limit survival to 12 months or less;
  • Treatment with erythropoietin or myeloid growth factors during prior 21 days or androgenic hormones during prior 13 days;
  • Active HIV, viral hepatitis type B or C;
  • Treatment with investigational drugs during prior 30 days;
  • Within the 28-day screening period, documented red cell folate deficiency, as evidenced by red blood cell folate (not serum folate) or vitamin B12 deficiency

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: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Azacitidine
Study Drug plus best supportive care. Treatment with erythropoietin was not permitted
Lék: Azacitidine
Azacitidine was injected subcutaneously (SC) at an initial dose of 75mg/m^2/day for 7 days. The 7-day dosing was repeated every 28 days with dose adjustment based on predefined hematology and renal laboratory results. Number of cycles: Azacitidine treatment was to be continued until the end of the study unless treatment was discontinued due to unacceptable toxicity, relapse after complete or partial response, transformation to AML or disease progression.
Ostatní jména:
  • AZA
Aktivní komparátor: Conventional Care
Physician choice of low dose cytarabine (plus best supportive care), standard chemotherapy (plus best supportive care) or best supportive care (only). Treatment with erythropoietin was not permitted
Jiný: Physician Choice

Physician Choice was one of three options:

  • Best supportive care (BSC) alone,
  • Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or
  • Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or mitoxantrone) on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to 70 days from the start of the previous cycle).

All three options included best supportive care

Ostatní jména:
  • cytarabin
  • antracyklin

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Kaplan-Meier Estimates for Median Time to Death From Any Cause
Časové okno: Day 1 (randomization) to 42 months
Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.
Day 1 (randomization) to 42 months
Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause
Časové okno: Day 1 (randomization) to 42 months

Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.

Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification.
Day 1 (randomization) to 42 months
Number of Participants Who Died
Časové okno: 42 months
Count of participants who died during the study
42 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First
Časové okno: Day 1 (randomization) to 42 months
The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.
Day 1 (randomization) to 42 months
Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)
Časové okno: Day 1 (randomization) to 42 months
The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.
Day 1 (randomization) to 42 months
Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline
Časové okno: Day 1 (randomization) to 42 months
Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
Day 1 (randomization) to 42 months
Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline
Časové okno: Day 1 (randomization) to 42 months
Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
Day 1 (randomization) to 42 months
Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline
Časové okno: Day 1 (randomization) to 42 months
Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
Day 1 (randomization) to 42 months
Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline
Časové okno: Day 1 (randomization) to 42 months
Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.
Day 1 (randomization) to 42 months
Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)
Časové okno: Day 1 to 42 months

Investigator determined responses followed IWG criteria for

  • complete remission(CR): repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia
  • partial remission(PR) is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment
  • stable disease(SD) is a failure to achieve at least a partial remission, but with no evidence of progression for at least 2 months.
Day 1 to 42 months
Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee
Časové okno: Day 1 to 42 months

IWG 2000 Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L.

Erythroid response: Major->20g/L increase or transfusion independent. Minor- 10-20g/L increase or >=50% decrease in transfusion requirements.

Platelet response: Major-absolute increase of >=30x10^9/L or platelet transfusion independence. Minor->=50% increase.

Neutrophil response: Major->=100% increase or an absolute increase of >0.5x10^9/L. Minor->=100% increase and absolute increase of <0.5x10^9/L.
Day 1 to 42 months
Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause
Časové okno: Day 1 (randomization) to 42 months
The time to disease progression, relapse after complete or partial remission (CR, PR), or death from any cause was defined as the time from the date of randomization until the first date of documented disease progression, relapse after CR or PR, or death from any cause.
Day 1 (randomization) to 42 months
Duration of Any Hematologic Improvement
Časové okno: Day 1 (randomization) to 42 months
The duration of improvement was defined as the time from the date of hematologic improvement until the date of first documented progression or relapse after hematologic improvement or death from any cause.
Day 1 (randomization) to 42 months
Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals
Časové okno: Day 1 (randomization) to 42 months
The on-treatment adverse event rate of infection requiring IV antibiotics, antifungals, or antivirals per patient-years. The on-treatment period was considered the period from the date of randomization to the last treatment study visit.
Day 1 (randomization) to 42 months
Number of Participants in Different Categories of Adverse Experiences During Core Study Period
Časové okno: Day 1 (randomization) to 42 months
Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months). The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.
Day 1 (randomization) to 42 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Celgene

Vyšetřovatelé

  • Ředitel studie: CL Beach, Celgene Corporation

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

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)

1. listopadu 2003

Primární dokončení (Aktuální)

1. července 2007

Dokončení studie (Aktuální)

1. července 2007

Termíny zápisu do studia

První předloženo

31. října 2003

První předloženo, které splnilo kritéria kontroly kvality

4. listopadu 2003

První zveřejněno (Odhad)

5. listopadu 2003

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. října 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. října 2019

Naposledy ověřeno

1. října 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • AZA PH GL 2003 CL001

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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