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Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

18. února 2020 aktualizováno: Gilead Sciences

A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

252

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
      • Darlinghurst, New South Wales, Austrálie, 2010
        • Holdsworth House Medical Practice
    • Victoria
      • Melbourne, Victoria, Austrálie, 3004
        • Clinical Research Infectious Diseases Department- Alfred Hospital
      • Prahran, Victoria, Austrálie, 3181
        • Prahran Market Clinic
  • Dominikánská republika
      • Santo Domingo, Dominikánská republika, 99999
        • Instituto Dominicano de Estudios Virologicos (IDEV)
  • Francie
      • Lyon, Francie, 69004
        • Hopital de la croix rousse
      • Paris, Francie, 75651
        • GHPS Service des maladies infectieuses et tropicales pavillon Laveran unité de recherche clinique
  • Holandsko
      • Utrecht, Holandsko, 3584 CX
        • University Medical Center Utrecht
  • Mexiko
    • Jalisco
      • Guadalajara, Jalisco, Mexiko, 44340
        • Hospital Civil de Guadalajara Dr. Juan I. Menchaca
  • Spojené království
      • Brighton, Spojené království, BN2 1ES
        • Brighton & Sussex University Hospitals NHS Trust
      • London, Spojené království, SE5 9RJ
        • Kings College London
      • London, Spojené království, Sw10 9NH
        • Chelsea and Westminster NHS Foundation Trust Hospital
      • Manchester, Spojené království, M13 0FH
        • Central Manchester University Hospitals NHS Foundation Trust
  • Spojené státy
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85015
        • Pueblo Family Physicians
      • Phoenix, Arizona, Spojené státy, 85006
        • Maricopa Integrated Health System - McDowell Clinic
    • Arkansas
      • Little Rock, Arkansas, Spojené státy, 72207
        • Health For Life Clinic Pllc
    • California
      • Beverly Hills, California, Spojené státy, 90211
        • Pacific Oaks Medical Group
      • Hayward, California, Spojené státy, 94545
        • Kaiser Permanente
      • Long Beach, California, Spojené státy, 90813
        • Long Beach Education and Research Consultants
      • Los Angeles, California, Spojené státy, 90069
        • Anthony Mills MD, Inc
      • Los Angeles, California, Spojené státy, 90036
        • Peter J Ruane, MD, Inc
      • Los Angeles, California, Spojené státy, 90028
        • LA Gay & Lesbian Center - Jeffrey Goodman Special Care Clinic
      • Palm Springs, California, Spojené státy, 92262
        • Desert Medical Group Inc. dba Desert Oasis Healthcare Medical Group
      • Sacramento, California, Spojené státy, 95825
        • Kaiser Permanente Medical Group
      • San Francisco, California, Spojené státy, 94109
        • Metropolis Medical
      • San Francisco, California, Spojené státy, 94118
        • Kaiser Permanente CTU San Francisco
    • Colorado
      • Aurora, Colorado, Spojené státy, 80045
        • University of Colorado
      • Denver, Colorado, Spojené státy, 80206
        • National Jewish Health
    • District of Columbia
      • Washington, District of Columbia, Spojené státy, 20009
        • Dupont Circle Physician's Group
    • Florida
      • Fort Lauderdale, Florida, Spojené státy, 33316
        • Gary J. Richmond, MD PA
      • Fort Pierce, Florida, Spojené státy, 34982
        • Midway Immunology and Research Center
      • Orlando, Florida, Spojené státy, 32806
        • Idocf/Valuhealthmd
      • Tampa, Florida, Spojené státy, 33602
        • University of South Florida
      • West Palm Beach, Florida, Spojené státy, 33401
        • Triple O Research Institute, P.A.
      • Wilton Manors, Florida, Spojené státy, 33305
        • Rowan Tree Medical, P.A.
    • Georgia
      • Decatur, Georgia, Spojené státy, 30033
        • Infectious Disease Specialists of Atlanta
      • Macon, Georgia, Spojené státy, 31210
        • Mercer University
    • Indiana
      • Indianapolis, Indiana, Spojené státy, 46202
        • Indiana University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02111
        • Community Research Initiative of New England
      • Springfield, Massachusetts, Spojené státy, 01105
        • The Research Institute
    • Michigan
      • Berkley, Michigan, Spojené státy, 48210
        • Be Well Medical Center, P.C.
      • Detroit, Michigan, Spojené státy, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, Spojené státy, 55415
        • Hennepin County Medical Center
    • Missouri
      • Kansas City, Missouri, Spojené státy, 64111
        • The Kansas City Care Clinic (KC Free Health Clinic)
      • Saint Louis, Missouri, Spojené státy, 63139
        • Southampton Healthcare, Inc.
    • New Jersey
      • Neptune, New Jersey, Spojené státy, 07754
        • Jersey Shore University Medical Center
      • Newark, New Jersey, Spojené státy, 07102
        • Saint Michael's Medical Center
    • New Mexico
      • Santa Fe, New Mexico, Spojené státy, 87505
        • Southwest CARE Center
    • New York
      • Albany, New York, Spojené státy, 12208
        • Albany Medical College
      • Albany, New York, Spojené státy, 12208
        • Upstate Infectious Diseases Associates
      • Bronx, New York, Spojené státy, 10467
        • Montefiore Medical Center
      • Bronx, New York, Spojené státy, 10461
        • Jacobi Medical Center
      • Manhasset, New York, Spojené státy, 11030
        • North Shore University Hospital/Division of Infectious Diseases
      • Rochester, New York, Spojené státy, 14607
        • Aids Care
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45267-0405
        • University of Cincinnati
      • Cleveland, Ohio, Spojené státy, 44109
        • MetroHealth Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, Spojené státy, 19104
        • University of PA HIV Clinical Trials Unit
    • Texas
      • Bellaire, Texas, Spojené státy, 77401
        • St. Hope Foundation
      • Dallas, Texas, Spojené státy, 75246
        • North Texas Infectious Diseases Consultants, PA
      • Harlingen, Texas, Spojené státy, 78550
        • Garcias' Family Health Group
      • Houston, Texas, Spojené státy, 77004
        • Therapeutic Concepts, PA
      • Houston, Texas, Spojené státy, 77098
        • Gordon E. Crofoot MD, PA
    • Washington
      • Seattle, Washington, Spojené státy, 98104
        • Peter Shalit, MD
  • Thajsko
      • Bangkok, Thajsko, 10400
        • Faculty of Medicine Ramathibodi Hospital, Mahidol University
      • Bangkok, Thajsko, 10330
        • HIV-NAT, Thai Red Cross AIDS Research Centre
      • Bangkok, Thajsko, 10700
        • Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital
      • Khon Kaen, Thajsko, 40002
        • Srinagarind Hospital, Khon Kaen University
  • Španělsko
      • Barcelona, Španělsko, 8907
        • Hospital Universitari de Bellvitge
      • Barcelona, Španělsko, 8916
        • Germans Trias i Pujol University Hospital
      • Madrid, Španělsko, 28046
        • Hospital La Paz

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

Key Inclusion Criteria:

Cohort 1 (treatment-experienced switch)

  • Must not have a history of known resistance to elvitegravir (EVG), tenofovir disoproxil fumarate (TDF), or emtricitabine (FTC)
  • Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels (according to the local assay being used) in the 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening
  • Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the Cockcroft-Gault formula for creatinine clearance, using actual weight
  • May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that study is complete; or currently receiving Stribild® (STB) or atazanavir (ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that study is complete.

Cohort 2 (treatment-naive)

  • Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
  • Screening genotype report provided by Gilead Sciences must show sensitivity to EVG, FTC, and TDF
  • No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PrEP), or post-exposure prophylaxis (PEP), up to 6 months prior to screening
  • Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine clearance, using actual weight

All Cohorts:

All individuals must meet all of the following inclusion criteria to be eligible for participation in this study:

  • The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • CD4+ count of ≥ 50 cells/μL
  • Stable renal function: serum creatinine measurements to be taken at least once (within three months of screening)
  • Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without change in medical management, for 3 months prior to baseline
  • Normal electrocardiogram (ECG)
  • Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN
  • Females of childbearing potential must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence) from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
  • Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
  • Males must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product. A highly effective method of contraception is defined as two separate forms of contraception, one of which must be an effective barrier method, or males must be non-heterosexually active, or practice sexual abstinence

Key Exclusion Criteria:

  • A new AIDS-defining condition (excluding CD4 cell count and percentage criteria) diagnosed within the 30 days prior to screening,with the exception of the first two bullet points
  • Hepatitis C virus (HCV) antibody positive. Individuals who are HCV positive, but have a documented negative HCV RNA, are eligible
  • Hepatitis B surface antigen (HBVsAg) positive
  • Individuals receiving drug treatment for Hepatitis C, or individuals who are anticipated to receive treatment for Hepatitis C during the course of the study
  • Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
  • A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • Individuals on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone and dexamethasone)
  • Individuals receiving ongoing therapy with any medications not to be used with EVG, COBI, FTC, or TAF or individuals with any known allergies to the excipients of E/C/F/TAF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: E/C/F/TAF
Participants will receive E/C/F/TAF for 144 weeks. Following Week 144, in countries where E/C/F/TAF is not available (except for the United Kingdom), participants will be given the option to continue in the study and receive E/C/F/TAF for another 48 weeks, or until the product becomes available through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever comes first.
Lék: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Ostatní jména:
  • Genvoya®

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
Časové okno: Baseline; Week 24
eGFR is a measurement of the kidney's ability to filter blood.
Baseline; Week 24
Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24
Časové okno: Baseline; Week 24
eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.
Baseline; Week 24
Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24
Časové okno: Baseline; Week 24
eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.
Baseline; Week 24

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy
Časové okno: Baseline; Week 2, 4, or 8; Week 24
aGFR was directly measured using iohexol plasma clearance (CLiohexol).
Baseline; Week 2, 4, or 8; Week 24
Percent Change From Baseline in C-type Collagen Sequence (CTX) at Weeks 24 and 48
Časové okno: Baseline; Weeks 24 and 48
CTX is a biomarker of bone turnover.
Baseline; Weeks 24 and 48
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 24 and 48
Časové okno: Baseline; Weeks 24 and 48
P1NP is a biomarker of bone turnover.
Baseline; Weeks 24 and 48
Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144
Časové okno: Baseline; Weeks 24, 48, 96, and 144
Urine RBP is a renal biomarker which is used to evaluate drug-induced kidney injury.
Baseline; Weeks 24, 48, 96, and 144
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144
Časové okno: Baseline; Weeks 24, 48, 96, and 144
Urine beta-2-microglobulin is a renal biomarker which is used to evaluate drug-induced kidney injury.
Baseline; Weeks 24, 48, 96, and 144
Percentage of Participants Experiencing Adverse Events or Graded Laboratory Abnormalities
Časové okno: Baseline up to Week 240 plus 30 days
Adverse events (AEs) and graded laboratory abnormalities occurring during the E/C/F/TAF treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.
Baseline up to Week 240 plus 30 days
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Weeks 24, 48, 96, and 144
Časové okno: Weeks 24, 48, 96, and 144
The percentage of participants achieving HIV-1 RNA < 50 Copies/mL at Weeks 24, 48, 96, and 144 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Weeks 24, 48, 96, and 144
Pharmacokinetic (PK) Parameter: Cmax of TAF
Časové okno: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Cmax is defined as the maximum concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: Tmax of TAF
Časové okno: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Tmax is defined as the time of Cmax. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: Clast of TAF
Časové okno: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Clast is defined as the last observable concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: Tlast of TAF
Časové okno: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Tlast is defined as the time of Clast. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: λz of TAF
Časové okno: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
λz is defined as the terminal elimination rate constant. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: AUCtau of TAF
Časové okno: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: t1/2 of TAF
Časové okno: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
PK Parameter: AUCtau of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cell (PBMC) for Participants Enrolled in PK/PD Sub-study
Časové okno: Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
TFV-DP is an active phosphorylated metabolite of tenofovir alafenamide. AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.
Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose
Change From Baseline in the eGFR_CG at Weeks 48, 96, and 144
Časové okno: Baseline; Weeks 48, 96, and 144
eGFR is a measurement of the kidney's ability to filter blood.
Baseline; Weeks 48, 96, and 144
Change From Baseline in eGFR_CKD-EPI,cysC at Weeks 48, 96, and 144
Časové okno: Baseline; Weeks 48, 96, and 144
eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.
Baseline; Weeks 48, 96, and 144
Change From Baseline in eGFR_CKD-EPI,Creatinine at Weeks 48, 96, and 144
Časové okno: Baseline; Weeks 48, 96, and 144
eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.
Baseline; Weeks 48, 96, and 144

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Gilead Sciences

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

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)

27. března 2013

Primární dokončení (Aktuální)

31. července 2014

Dokončení studie (Aktuální)

18. července 2018

Termíny zápisu do studia

První předloženo

22. března 2013

První předloženo, které splnilo kritéria kontroly kvality

22. března 2013

První zveřejněno (Odhad)

26. března 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. března 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. února 2020

Naposledy ověřeno

1. června 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • GS-US-292-0112
  • 2013-000516-25 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Časový rámec sdílení IPD

18 months after study completion

Kritéria přístupu pro sdílení IPD

A secured external environment with username, password, and RSA code.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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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Podmínky

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