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Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed

maanantai 24. elokuuta 2020 päivittänyt: Gilead Sciences

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching From Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 mg QD in Subjects With Chronic Hepatitis B Who Are Virologically Suppressed

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

490

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Espanja
      • Barcelona, Espanja
      • Majadahonda, Espanja
  • Hong Kong
      • Hong Kong, Hong Kong
      • Kowloon, Hong Kong
  • Italia
      • Milan, Italia, 20122
  • Kanada
      • Edmonton, Kanada
      • Toronto, Kanada
      • Vancouver, Kanada
  • Korean tasavalta
      • Daegu, Korean tasavalta, 700-721
      • Seoul, Korean tasavalta
      • Seoul, Korean tasavalta, 135-710
      • Seoul, Korean tasavalta, 05505
      • Seoul, Korean tasavalta, 03722
      • Seoul, Korean tasavalta, 152-703
      • Seoul, Korean tasavalta, 06973
      • Seoul, Korean tasavalta, 03830
    • Gyeonggi-d
      • Goyang, Gyeonggi-d, Korean tasavalta
  • Taiwan
      • Chiayi City, Taiwan, 60002
      • Kaohsiung, Taiwan
      • Taipei City, Taiwan, 10002
  • Yhdistynyt kuningaskunta
      • London, Yhdistynyt kuningaskunta
      • London, Yhdistynyt kuningaskunta, E1 1BB
  • Yhdysvallat
    • California
      • Los Angeles, California, Yhdysvallat
      • Palo Alto, California, Yhdysvallat
      • Pasadena, California, Yhdysvallat
      • San Diego, California, Yhdysvallat
      • San Francisco, California, Yhdysvallat
      • San Jose, California, Yhdysvallat
    • Maryland
      • Baltimore, Maryland, Yhdysvallat
    • Massachusetts
      • Boston, Massachusetts, Yhdysvallat
    • Michigan
      • Novi, Michigan, Yhdysvallat
    • New York
      • Flushing, New York, Yhdysvallat
      • Flushing, New York, Yhdysvallat, 11355
      • New York, New York, Yhdysvallat
      • New York, New York, Yhdysvallat, 10029
    • Pennsylvania
      • Philadelphia, Pennsylvania, Yhdysvallat
      • Philadelphia, Pennsylvania, Yhdysvallat, 19107
    • Tennessee
      • Nashville, Tennessee, Yhdysvallat
    • Texas
      • Sugar Land, Texas, Yhdysvallat, 77478

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Key Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
  • Adult male and non-pregnant, non-lactating females
  • Documented evidence of chronic hepatitis B virus (HBV) infection previously
  • Maintained on tenofovir disoproxil fumarate (TDF) 300 mg once daily for at least 48 weeks, and as monotherapy for chronic hepatitis B for at least 24 weeks with viral suppression (HBV DNA < lower limit of quantitation) for a minimum of 12 weeks prior to screening
  • Adequate renal function
  • Normal Electrocardiogram

Key Exclusion Criteria:

  • Pregnant women or women who are breastfeeding
  • Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study.
  • Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or human immunodeficiency virus (HIV)
  • Evidence of hepatocellular carcinoma
  • Current evidence of, or recent (≤ 5 year) history of clinical hepatic decompensation

  • Abnormal hematological and biochemical parameters, including:

    • Hemoglobin < 10 g/dL
    • Absolute neutrophil count < 750/mm^3
    • Platelets ≤ 50,000/mm^3
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 × upper limit of the normal (ULN)
    • Albumin < 3.0 mg/ dL
    • International normalized ratio (INR) > 1.5 × ULN (unless stable on anticoagulant regimen)
    • Total bilirubin > 2.5 × ULN
  • Received solid organ or bone marrow transplant
  • Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (eg, basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.
  • Currently receiving therapy with immunomodulators (eg, corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
  • Individuals receiving ongoing therapy with drugs not to be used with TAF or TDF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
  • Use of investigational agents within 3 months of screening, unless allowed by the sponsor

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: TAF 25 mg
Double-blind (DB) phase: TAF 25 mg + TDF placebo for up to 53 weeks. Open-label extension (OLE) phase: TAF 25 mg for up to 52 weeks.
Lääke: TAF
25 mg tabletti suun kautta kerran päivässä
Muut nimet:
  • Vemlidy®
  • GS-7340
Lääke: TDF Placebo
Tabletti kerran päivässä suun kautta
Active Comparator: TDF 300 mg
DB phase: TDF 300 mg + TAF placebo for up to 50 weeks. OLE phase: TAF 25 mg for up to 52 weeks.
Lääke: TAF
25 mg tabletti suun kautta kerran päivässä
Muut nimet:
  • Vemlidy®
  • GS-7340
Lääke: TDF
300 mg tabletti suun kautta kerran päivässä
Muut nimet:
  • Viread®
Lääke: TAF Placebo
Tabletti kerran päivässä suun kautta

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
Aikaikkuna: Week 48

The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:

  1. Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or

  2. Did not have on-treatment HBV DNA data available in the Week 48 analysis window and

    • Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or
    • Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL
Week 48

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm
Aikaikkuna: Week 96

The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:

  1. Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or

  2. Did not have on-treatment HBV DNA data available in the Week 96 analysis window and

    • Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or
    • Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL
Week 96
Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48
Aikaikkuna: Weeks 48
The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. Missing=Failure (M = F) approach was used for analysis.
Weeks 48
Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48
Aikaikkuna: Week 48
The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches.
Week 48
Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96
Aikaikkuna: Week 96
The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. M = F approach was used for analysis.
Week 96
Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96
Aikaikkuna: Week 96
The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches.
Week 96
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48
Aikaikkuna: Week 48
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.
Week 48
Percentage of Participants With HBeAg Seroconversion at Week 48
Aikaikkuna: Week 48
HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Week 48
Percentage of Participants With HBeAg Loss at Week 96
Aikaikkuna: Week 96
HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.
Week 96
Percentage of Participants With HBeAg Seroconversion at Week 96
Aikaikkuna: Week 96
HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Week 96
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
Aikaikkuna: Week 48
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.
Week 48
Percentage of Participants With HBsAg Seroconversion at Week 48
Aikaikkuna: Week 48
HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Week 48
Percentage of Participants With HBsAg Loss at Week 96
Aikaikkuna: Week 96
HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.
Week 96
Percentage of Participants With HBsAg Seroconversion at Week 96
Aikaikkuna: Week 96
HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
Week 96
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)
Aikaikkuna: Week 48
Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
Week 48
Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)
Aikaikkuna: Week 48
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
Week 48
Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)
Aikaikkuna: Week 96
Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
Week 96
Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)
Aikaikkuna: Week 96
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
Week 96
Change From Baseline in FibroTest® Score at Week 48
Aikaikkuna: Baseline; Week 48
The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
Baseline; Week 48
Change From Baseline in FibroTest® Score at Week 96
Aikaikkuna: Baseline; Week 96
The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
Baseline; Week 96
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Aikaikkuna: Baseline; Week 48
Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
Baseline; Week 48
Percent Change From Baseline in Hip BMD at Week 96
Aikaikkuna: Baseline; Week 96
Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
Baseline; Week 96
Percent Change From Baseline in Spine BMD at Week 48
Aikaikkuna: Baseline; Week 48
Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
Baseline; Week 48
Percent Change From Baseline in Spine BMD at Week 96
Aikaikkuna: Baseline; Week 96
Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
Baseline; Week 96
Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48
Aikaikkuna: Baseline; Week 48

Cockcroft-Gault formula is as follows:

  • For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)
  • For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).

Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
Baseline; Week 48
Change From Baseline in eGFR-CG at Week 96
Aikaikkuna: Baseline; Week 96

Cockcroft-Gault formula is as follows:

  • For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)
  • For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).

Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
Baseline; Week 96

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Gilead Sciences

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Torstai 29. joulukuuta 2016

Ensisijainen valmistuminen (Todellinen)

Maanantai 10. syyskuuta 2018

Opintojen valmistuminen (Todellinen)

Torstai 30. tammikuuta 2020

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 29. marraskuuta 2016

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 29. marraskuuta 2016

Ensimmäinen Lähetetty (Arvio)

Torstai 1. joulukuuta 2016

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 14. syyskuuta 2020

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 24. elokuuta 2020

Viimeksi vahvistettu

Lauantai 1. elokuuta 2020

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • GS-US-320-4018
  • 2016-003632-20 (EudraCT-numero)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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

IPD-jaon aikakehys

18 months after study completion

IPD-jaon käyttöoikeuskriteerit

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

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Krooninen hepatiitti B

Kliiniset tutkimukset TAF

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Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Venezuela

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

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