- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02979613
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Edmonton, Canadá
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Toronto, Canadá
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Vancouver, Canadá
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Daegu, Corea, república de, 700-721
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Seoul, Corea, república de
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Seoul, Corea, república de, 135-710
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Seoul, Corea, república de, 05505
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Seoul, Corea, república de, 03722
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Seoul, Corea, república de, 152-703
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Seoul, Corea, república de, 06973
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Seoul, Corea, república de, 03830
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Gyeonggi-d
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Goyang, Gyeonggi-d, Corea, república de
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Barcelona, España
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Majadahonda, España
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California
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Los Angeles, California, Estados Unidos
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Palo Alto, California, Estados Unidos
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Pasadena, California, Estados Unidos
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San Diego, California, Estados Unidos
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San Francisco, California, Estados Unidos
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San Jose, California, Estados Unidos
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Maryland
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Baltimore, Maryland, Estados Unidos
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Massachusetts
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Boston, Massachusetts, Estados Unidos
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Michigan
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Novi, Michigan, Estados Unidos
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New York
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Flushing, New York, Estados Unidos
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Flushing, New York, Estados Unidos, 11355
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New York, New York, Estados Unidos
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New York, New York, Estados Unidos, 10029
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos
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Philadelphia, Pennsylvania, Estados Unidos, 19107
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Tennessee
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Nashville, Tennessee, Estados Unidos
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Texas
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Sugar Land, Texas, Estados Unidos, 77478
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
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Milan, Italia, 20122
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London, Reino Unido
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London, Reino Unido, E1 1BB
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Chiayi City, Taiwán, 60002
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Kaohsiung, Taiwán
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Taipei City, Taiwán, 10002
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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Comprimido de 25 mg administrado por vía oral una vez al día
Otros nombres:
Comprimido administrado por vía oral una vez al día
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Comparador activo: 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.
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Comprimido de 25 mg administrado por vía oral una vez al día
Otros nombres:
Comprimido de 300 mg administrado por vía oral una vez al día
Otros nombres:
Comprimido administrado por vía oral una vez al día
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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
Periodo de tiempo: Week 48
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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:
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Week 48
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm
Periodo de tiempo: Week 96
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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:
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Week 96
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Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48
Periodo de tiempo: Weeks 48
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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.
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Weeks 48
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Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48
Periodo de tiempo: Week 48
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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.
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Week 48
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Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96
Periodo de tiempo: Week 96
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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.
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Week 96
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Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96
Periodo de tiempo: Week 96
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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.
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Week 96
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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48
Periodo de tiempo: Week 48
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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.
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Week 48
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Percentage of Participants With HBeAg Seroconversion at Week 48
Periodo de tiempo: Week 48
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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.
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Week 48
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Percentage of Participants With HBeAg Loss at Week 96
Periodo de tiempo: Week 96
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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.
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Week 96
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Percentage of Participants With HBeAg Seroconversion at Week 96
Periodo de tiempo: Week 96
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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.
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Week 96
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
Periodo de tiempo: Week 48
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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.
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Week 48
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Percentage of Participants With HBsAg Seroconversion at Week 48
Periodo de tiempo: Week 48
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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.
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Week 48
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Percentage of Participants With HBsAg Loss at Week 96
Periodo de tiempo: Week 96
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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.
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Week 96
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Percentage of Participants With HBsAg Seroconversion at Week 96
Periodo de tiempo: Week 96
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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.
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Week 96
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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)
Periodo de tiempo: Week 48
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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.
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Week 48
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Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)
Periodo de tiempo: Week 48
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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.
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Week 48
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Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)
Periodo de tiempo: Week 96
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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.
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Week 96
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Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)
Periodo de tiempo: Week 96
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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.
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Week 96
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Change From Baseline in FibroTest® Score at Week 48
Periodo de tiempo: Baseline; Week 48
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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.
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Baseline; Week 48
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Change From Baseline in FibroTest® Score at Week 96
Periodo de tiempo: Baseline; Week 96
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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.
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Baseline; Week 96
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Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Periodo de tiempo: Baseline; Week 48
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Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
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Baseline; Week 48
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Percent Change From Baseline in Hip BMD at Week 96
Periodo de tiempo: Baseline; Week 96
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Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
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Baseline; Week 96
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Percent Change From Baseline in Spine BMD at Week 48
Periodo de tiempo: Baseline; Week 48
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Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
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Baseline; Week 48
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Percent Change From Baseline in Spine BMD at Week 96
Periodo de tiempo: Baseline; Week 96
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Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
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Baseline; Week 96
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Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48
Periodo de tiempo: Baseline; Week 48
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Cockcroft-Gault formula is as follows:
Change from baseline was calculated as the value at Week 48 minus the value at Baseline. |
Baseline; Week 48
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Change From Baseline in eGFR-CG at Week 96
Periodo de tiempo: Baseline; Week 96
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Cockcroft-Gault formula is as follows:
Change from baseline was calculated as the value at Week 96 minus the value at Baseline. |
Baseline; Week 96
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Hepatitis, Viral, Humana
- Infecciones por Hepadnaviridae
- Infecciones por virus de ADN
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B Crónica
- Hepatitis Crónica
Otros números de identificación del estudio
- GS-US-320-4018
- 2016-003632-20 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Hepatitis B crónica
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The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesAún no reclutando
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Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.DesconocidoHepatitis b crónica
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Tongji HospitalGilead SciencesReclutamiento
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Jiangsu HengRui Medicine Co., Ltd.Desconocido
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Changhai HospitalTerminadoHepatitis b crónicaPorcelana
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Nanfang Hospital of Southern Medical UniversityReclutamiento
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IlDong Pharmaceutical Co LtdReclutamientoHepatitis b crónicaCorea, república de
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Antios Therapeutics, IncTerminadoHepatitis b crónicaEstados Unidos
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Xi'an Xintong Pharmaceutical Research Co.,Ltd.Desconocido
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National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu Chi Hospital... y otros colaboradoresReclutamientoHepatitis b crónica | Reactivación de Hepatitis BTaiwán
Ensayos clínicos sobre TAF
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Gilead SciencesReclutamientoInfección por VIH-1Estados Unidos, Tailandia, Uganda, Sudáfrica
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Gilead SciencesTerminadoInfección por VIH-1Estados Unidos, República Dominicana, Puerto Rico, Tailandia
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Huashan HospitalThe First Affiliated Hospital with Nanjing Medical University; Peking University... y otros colaboradoresReclutamiento
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Gilead SciencesTerminado
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Gilead SciencesReclutamientoInfección por VIH-1Estados Unidos, Francia, Canadá
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Gilead SciencesAún no reclutando
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Gilead SciencesTerminadoVHB | Infecciones crónicas por VHBPorcelana
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Tulika Singh, MDGilead SciencesReclutamientoInfección por VIH-1Estados Unidos
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Fundacion SEIMC-GESIDATerminado
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Gilead SciencesTerminadoHepatitis B crónica HBeAg negativoHong Kong, Estados Unidos, Reino Unido, Canadá, Australia, España, Taiwán, India, Japón, Polonia, Rumania, Federación Rusa, Corea, república de, Italia, Nueva Zelanda, Francia, Pavo