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

16 октября 2019 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

358

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Azacitidine
Study Drug plus best supportive care. Treatment with erythropoietin was not permitted
Лекарство: 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.
Другие имена:
  • АЗА
Активный компаратор: 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
Другой: 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

Другие имена:
  • цитарабин
  • антрациклин

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Kaplan-Meier Estimates for Median Time to Death From Any Cause
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 42 months
Count of participants who died during the study
42 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Celgene

Следователи

  • Директор по исследованиям: CL Beach, Celgene Corporation

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 ноября 2003 г.

Первичное завершение (Действительный)

1 июля 2007 г.

Завершение исследования (Действительный)

1 июля 2007 г.

Даты регистрации исследования

Первый отправленный

31 октября 2003 г.

Впервые представлено, что соответствует критериям контроля качества

4 ноября 2003 г.

Первый опубликованный (Оценивать)

5 ноября 2003 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

29 октября 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

16 октября 2019 г.

Последняя проверка

1 октября 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • AZA PH GL 2003 CL001

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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