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A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)

17 августа 2026 г. обновлено: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB

The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

SPECTRA-TB is a Phase 2C, randomized, open-label trial of stratified medicine principles in TB treatment to identify the optimal duration of the HP1500ZM regimen for participants in the lower-risk stratum and to demonstrate improved TB-related favorable outcomes of this regimen in the higher-risk stratum. The study risk stratification includes a higher-risk group (1 control arm and 1 experimental arm) and a lower-risk group (1 control and 5 experimental arms).

Eligible participants will be stratified as either lower- or higher-risk based on the risk stratification algorithm which is based on the following results obtained during the screening period: Xpert MTB/RIF Ultra CT value, extent of disease on chest X-ray, age, BMI, sex at birth, diabetes status, and HIV status using the SPECTRA-TB risk algorithm prior to randomization. Those classified into the lower-risk group (consisting of the low and moderate risk randomization strata to facilitate balancing of risk within each lower-risk treatment arm) will be randomized to SOC or one of five durations of the experimental regimens while those classified into the higher-risk group will be randomized to receive either SOC or a single fixed duration of the experimental regimen. The lower and higher-risk groups will have the following arms:

  • Lower-risk: 10, 12, 14, 16, 18, and 26 weeks (5 experimental arms [weeks 10-18] and one 26-week SOC arm with 100 participants in each arm).
  • Higher-risk: Two arms with 26 weeks duration (one SOC arm with 100 participants and one experimental arm with 200 participants).

All participants will be followed for 72 weeks from randomization for outcomes of efficacy, safety, and tolerability. Participants will be monitored closely for Possible Poor Treatment Response (PPTR), TB treatment failure or TB recurrence, safety, tolerability, and loss to follow-up.

Тип исследования

Интервенционный

Регистрация (Оцененный)

900

Фаза

  • Фаза 2

Контакты и местонахождение

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

Контакты исследования

  • Имя: Gustavo Velásquez, MD, MPH
  • Номер телефона: 628-206-2400
  • Электронная почта: gustavo.velasquez@ucsf.edu

Места учебы

  • Австралия
  • Аргентина
      • Buenos Aires, Аргентина
  • Ботсвана
      • Gaborone, Ботсвана
        • Gaborone CRS (Site #: 12701)
        • Контакт:
          • Unoda Chakalisa, MBBCh
          • Номер телефона: 267-3930388
          • Электронная почта: uchakalisa@bhp.org.bw
      • Gaborone, Ботсвана
        • Molepolole CRS (Site # 12702)
        • Контакт:
  • Бразилия
      • Rio Grande, Бразилия
        • Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site # 12201)
        • Контакт:
      • Rio de Janeiro, Бразилия, 21040-360
        • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site #: 12101)
        • Контакт:
  • Вьетнам
      • Hanoi, Вьетнам, 100000
        • National Lung Hospital (Site #: 32483)
        • Контакт:
          • Tran Viet Ha
          • Номер телефона: 84-912-785886
          • Электронная почта: vietha@live.unc.edu
  • Гаити
      • Port-au-Prince, Гаити, HT-6110
        • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site #: 31730)
        • Контакт:
          • Yvetot Joseph, MD
          • Номер телефона: 509-36832867
          • Электронная почта: yvetotjoseph@gheskio.org
      • Port-au-Prince, Гаити, HT-6110
        • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site #: 30022)
        • Контакт:
  • Зимбабве
      • Harare, Зимбабве, 263663
        • Milton Park CRS (Site #: 30313)
        • Контакт:
          • Patience N. Sibanda
          • Номер телефона: 263-774-361790
          • Электронная почта: psibanda@uz-ctrc.org
  • Индия
      • Chennai, Индия
        • YRG CARE CRS (Site # 32075)
        • Контакт:
          • Rifa Khan, M.B.B.S., M.P.H.
          • Электронная почта: rifa@yrgcare.org
    • Maharashtra
      • Pune, Maharashtra, Индия, 411001
        • Byramjee Jeejeebhoy Government Medical College (BJGMC) CRS (Site #: 31441)
        • Контакт:
          • Nishi Suryavanshi, Ph.D.
          • Номер телефона: 91-98-23248979
          • Электронная почта: nsuryav1@jhmi.edu
  • Кения
    • Rift Valley
      • Eldoret, Rift Valley, Кения, 30100
        • Moi University Clinical Research Center (MUCRC) CRS (Site #: 12601)
        • Контакт:
          • Viola C. Kirui
          • Номер телефона: 254-711729856
          • Электронная почта: viola.kirui@gmail.com
      • Kericho, Rift Valley, Кения, 20200
        • Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site #: 12501)
        • Контакт:
          • Samwel K. Chirchir, R.N., B.Sc.
          • Номер телефона: 254-52-2036100
          • Электронная почта: Samwel.Chirchir@usamru-k.org
  • Малави
      • Blantyre, Малави
        • Blantyre CRS (Site #: 30301)
        • Контакт:
          • Dumisile Huwa
          • Номер телефона: 265-1811885
          • Электронная почта: dhuwa@jhp.mw
    • Central Region
      • Lilongwe, Central Region, Малави
        • Malawi CRS (Site #: 12001)
        • Контакт:
  • Мексика
      • Mexico City, Мексика, 14000
        • Nutrición-Mexico CRS (Site #: 32078)
        • Контакт:
          • Brenda Crabtree Ramirez
          • Номер телефона: 5504 52-5554870900
          • Электронная почта: brenda.crabtree@infecto.mx
  • Перу
      • Callao, Перу
        • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site # 31970)
        • Контакт:
      • Lima, Перу
        • Barranco CRS (Site #: 11301)
        • Контакт:
          • Consuelo Ramirez, C.N.M.
          • Номер телефона: 210 51-1-2067800
          • Электронная почта: ctristan@impactaperu.org
      • Lima, Перу
        • San Miguel CRS (Site # 11302)
        • Контакт:
      • Lima, Перу
        • Socios en Salud Sucursal Peru CRS (Site # 31985)
        • Контакт:
  • Таиланд
      • Bangkok, Таиланд
        • Siriraj Hospital, Mahidol University NICHD CRS (Site # 5115)
        • Контакт:
      • Chiang Mai, Таиланд, 50200
        • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site #: 31784)
        • Контакт:
          • Daralak Tavornprasit, R.N., M.Sc.
          • Номер телефона: 176 66-5-3936148
          • Электронная почта: daralak.t@cmu.ac.th
      • Chiang Rai, Таиланд
        • Chiangrai Prachanukroh Hospital NICHD CRS (Site # 5116)
        • Контакт:
    • Bangkok
      • Pathum Wan, Bangkok, Таиланд, 10330
        • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site #: 31802)
        • Контакт:
          • Parawee Thongpaeng
          • Номер телефона: 106 662-6523040
          • Электронная почта: parawee.t@hivnat.org
  • Танзания
      • Moshi, Танзания
        • Kilimanjaro Christian Medical Centre (KCMC) (Site # 5118)
        • Контакт:
  • Уганда
      • Kampala, Уганда, 10005
        • Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site (Site #: 12401)
        • Контакт:
          • Sandra Rwambuya, M.P.H.
          • Номер телефона: 256-772-779283
          • Электронная почта: dxr23@case.edu
      • Kampala, Уганда
        • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS (Site # 30293)
        • Контакт:
  • Филиппины
    • Cavite
      • Dasmariñas, Cavite, Филиппины, 4114
        • TB HIV Innovations and Clinical Research Foundation Corp. (Site #: 31981)
        • Контакт:
          • Maria Gler, MD
          • Номер телефона: 63-9178230431
          • Электронная почта: msgler@tbhivicr.org.ph

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

  • Ребенок
  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.
  • Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.
  • Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.
  • Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.
  • If living with HIV, has a CD4+ cell count of at least 50 cells/mm3 within 60 days before study entry.
  • If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.

  • Has laboratory test results within 7 days before study entry that meet all of the following:

    • alanine aminotransferase (ALT) no more than 3 times the upper limit of normal
    • total bilirubin no more than 2.5 times the upper limit of normal
    • creatinine no more than 2 times the upper limit of normal
    • potassium between 3.5 and 5.5 mEq/L
    • absolute neutrophil count at least 1000/mm3
    • hemoglobin at least 7.0 g/dL
    • platelet count at least 100,000/mm3
  • If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.

  • If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include:

    • condoms
    • intrauterine device (IUD) or intrauterine system (IUS)
    • cervical cap with spermicide
    • diaphragm with spermicide
  • If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation.
  • Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up.
  • Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required.

Exclusion Criteria:

  • TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.
  • Received more than 5 days of treatment for active TB within the 24 weeks before study entry.
  • Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs.
  • Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB.
  • Has a past history of suspected or confirmed drug-resistant TB of any type.
  • Is currently pregnant or breastfeeding.
  • Cannot take medicines by mouth.
  • Has an HIV/AIDS-related opportunistic infection at study entry.
  • Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared.
  • Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated.
  • Has alcohol-related liver disease.
  • Has liver cirrhosis.
  • Has a history of aortic aneurysm or aortic dissection.
  • Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors.
  • Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine.
  • Has a known history of acute intermittent porphyria.
  • Weighs less than 30 kg.
  • Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study.
  • Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients.
  • Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements.
  • Is currently taking part in another interventional clinical trial.

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: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Arm 1A: Higher-risk control group
Participants at higher risk of unfavorable outcome will receive 26 weeks of standard-of-care treatment consisting of isoniazid, rifampin, pyrazinamide, and ethambutol for 8 weeks, followed by isoniazid and rifampin for 18 weeks.
Лекарство: Isoniazid
Administered orally once daily
Лекарство: Rifampin
Administered orally once daily
Лекарство: Pyrazinamide
Administered orally once daily
Лекарство: Ethambutol
Administered orally once daily
Экспериментальный: Arm 1B: Higher-risk experimental group
Participants at higher risk of unfavorable outcome will receive 26 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Лекарство: Isoniazid
Administered orally once daily
Лекарство: Pyrazinamide
Administered orally once daily
Лекарство: Rifapentine
Administered orally once daily
Лекарство: Moxifloxacin
Administered orally once daily
Активный компаратор: Arm 2A: Lower-risk control group
Participants at lower risk of unfavorable outcome will receive 26 weeks of standard-of-care treatment consisting of isoniazid, rifampin, pyrazinamide, and ethambutol for 8 weeks, followed by isoniazid and rifampin for 18 weeks.
Лекарство: Isoniazid
Administered orally once daily
Лекарство: Rifampin
Administered orally once daily
Лекарство: Pyrazinamide
Administered orally once daily
Лекарство: Ethambutol
Administered orally once daily
Экспериментальный: Arm 2B: Lower-risk experimental group (10 week duration)
Participants at lower risk of unfavorable outcome will receive 10 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Лекарство: Isoniazid
Administered orally once daily
Лекарство: Pyrazinamide
Administered orally once daily
Лекарство: Rifapentine
Administered orally once daily
Лекарство: Moxifloxacin
Administered orally once daily
Экспериментальный: Arm 2C: Lower-risk experimental group (12 week duration)
Participants at lower risk of unfavorable outcome will receive 12 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Лекарство: Isoniazid
Administered orally once daily
Лекарство: Pyrazinamide
Administered orally once daily
Лекарство: Rifapentine
Administered orally once daily
Лекарство: Moxifloxacin
Administered orally once daily
Экспериментальный: Arm 2D: Lower-risk experimental group (14 week duration)
Participants at lower risk of unfavorable outcome will receive 14 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Лекарство: Isoniazid
Administered orally once daily
Лекарство: Pyrazinamide
Administered orally once daily
Лекарство: Rifapentine
Administered orally once daily
Лекарство: Moxifloxacin
Administered orally once daily
Экспериментальный: Arm 2E: Lower-risk experimental group (16 week duration)
Participants at lower risk of unfavorable outcome will receive 16 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Лекарство: Isoniazid
Administered orally once daily
Лекарство: Pyrazinamide
Administered orally once daily
Лекарство: Rifapentine
Administered orally once daily
Лекарство: Moxifloxacin
Administered orally once daily
Экспериментальный: Arm 2F: Lower-risk experimental group (18 week duration)
Participants at lower risk of unfavorable outcome will receive 18 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Лекарство: Isoniazid
Administered orally once daily
Лекарство: Pyrazinamide
Administered orally once daily
Лекарство: Rifapentine
Administered orally once daily
Лекарство: Moxifloxacin
Administered orally once daily

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Lower-risk group: Proportion of participants with sustained cure at 52 weeks after randomization
Временное ограничение: 52 weeks after randomization
Sustained cure is defined as: participant known to be alive at or after 52 weeks after randomization; sustained culture negativity at 52 weeks after randomization, defined as the last 2 liquid cultures collected at different visits being Mtb-negative without an intervening Mtb-positive result, with the last collected no earlier than 48 weeks after randomization; no treatment failure or relapse through 52 weeks after randomization; and no retreatment or additional TB treatment beyond assigned study treatment through 52 weeks after randomization. Participants will be classified as having presence of sustained cure, absence of sustained cure, or not assessable.
52 weeks after randomization
Lower-risk group: Proportion of participants with at least 1 new Grade 3 to 5 adverse event through 28 weeks after randomization
Временное ограничение: Baseline through 28 weeks after randomization
Occurrence of at least 1 new Grade 3 to 5 adverse event during the 28 weeks following randomization among participants in the lower-risk group, where 28 weeks is 2 weeks beyond the longest scheduled treatment duration of 26 weeks.
Baseline through 28 weeks after randomization

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Higher-risk group: Proportion of participants with sustained cure at 52 week after randomization
Временное ограничение: 52 weeks after randomization
Sustained cure is defined as: participant known to be alive at or after 52 weeks after randomization; sustained culture negativity at 52 weeks after randomization, defined as the last 2 liquid cultures collected at different visits being Mtb-negative without an intervening Mtb-positive result, with the last collected no earlier than 48 weeks after randomization; no treatment failure or relapse through 52 weeks after randomization; and no retreatment or additional TB treatment beyond assigned study treatment through 52 weeks after randomization. Participants will be classified as having presence of sustained cure, absence of sustained cure, or not assessable.
52 weeks after randomization
Higher-risk group: Proportion of participants with at least 1 new Grade 3 to 5 adverse event through 28 weeks after randomization
Временное ограничение: Baseline through 28 weeks after randomization
Occurrence of at least 1 new Grade 3 to 5 adverse event during the 28 weeks following randomization among participants in the higher-risk group, where 28 weeks is 2 weeks beyond the longest scheduled treatment duration of 26 weeks.
Baseline through 28 weeks after randomization
Proportion of participants with sustained cure at 72 weeks after randomization
Временное ограничение: 72 weeks after randomization
Sustained cure defined as for the primary efficacy outcome measure, except assessed with respect to 72 weeks.
72 weeks after randomization
Cumulative proportion of stable liquid mycobacterial culture conversion by 26 weeks after randomization
Временное ограничение: Baseline through 26 weeks after randomization
Stable culture conversion is defined as two negative cultures on two different days without an intervening positive culture (irrespective of positive cultures subsequent to stable culture conversion).
Baseline through 26 weeks after randomization
Mean liquid mycobacterial culture log10 days to positivity slope during the first 10 weeks after randomization
Временное ограничение: During the first 10 weeks after randomization
Liquid mycobacterial culture days to positivity during the 10 weeks following randomization.
During the first 10 weeks after randomization
Proportion of participants who prematurely discontinue study treatment
Временное ограничение: Baseline through 26 weeks after randomization
Occurrence of premature study treatment discontinuation for any reason other than when the participant has tuberculosis subsequently determined to be resistant to isoniazid, rifampicin, or fluoroquinolones.
Baseline through 26 weeks after randomization

Соавторы и исследователи

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

Спонсор

National Institute of Allergy and Infectious Diseases (NIAID)

Соавторы

ViiV Healthcare

Следователи

  • Учебный стул: Susan Dorman, MD, Medical University of South Carolina
  • Учебный стул: Gustavo Velásquez, MD, MPH, University of California, San Francisco
  • Учебный стул: Patrick Phillips, PhD, San Francisco General Hospital

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 (Оцененный)

30 октября 2026 г.

Первичное завершение (Оцененный)

5 июня 2029 г.

Завершение исследования (Оцененный)

22 октября 2029 г.

Даты регистрации исследования

Первый отправленный

6 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

12 мая 2026 г.

Первый опубликованный (Действительный)

19 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

19 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

17 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • A5414
  • 38987 (Другой идентификатор: DAIDS-ES ID)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Individual participant data that underlie results in the publication, after deidentification.

Сроки обмена IPD

Beginning 3 months following publication and available throughout period of funding of the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) by NIH.

Критерии совместного доступа к IPD

  • With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG.
  • For what types of analyses? To achieve aims in the proposal approved by the ACTG.
  • By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

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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